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Symposium to Explore the Impact of Vascular Dissections on Critical Limb Ischemia Patients at AMP 2018
A Case-Based Look at Below-the-Knee Lesions Post-Angioplasty

By | 2018 Press Releases, Press Releases

August 6, 2018 – WAYNE, Pa.–(BUSINESS WIRE)–Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today announced key presentations that will be featured during a CME symposium at the Amputation Prevention (AMP) Conference …

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Intact Vascular Welcomes Publication of iDissection Classification Study Results in Journal of Invasive Cardiology
Dissections post-atherectomy are significantly underdiagnosed on angiogram and are detectable utilizing intravascular ultrasound (IVUS)

By | 2018 Press Releases, Press Releases

July 11, 2018 – WAYNE, Pa.–(BUSINESS WIRE)–Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today welcomed the publication of the iDissection Classification trial results in the current issue of Journal of Invasive Cardiology.

Post-percutaneous transluminal angioplasty (“PTA”) dissections are often overlooked, underdiagnosed and left untreated. These dissections can compromise clinical outcomes in both the short and long term. The use of intravascular ultrasound (IVUS) has been found to help visualize the presence and severity of dissections not typically seen on angiography.

In the iDissection study, 15 patients with femoropopliteal disease were treated with atherectomy and adjunctive PTA. Angiographic and IVUS images utilizing ChromaFlo Imaging (Philips) were obtained at baseline, post-atherectomy and post-angioplasty and evaluated for the presence and severity of dissections. Dissections seen on angiography were graded per the NHLBI scale, and IVUS images were graded using the iDissection classification. All images were independently adjudicated by multiple core laboratories. While angiography identified 8 dissections, IVUS revealed 46 dissections—a ratio of 6:1. The iDissection study reveals that significant dissections may not be thoroughly observed with angiography yet are substantially more visible when using IVUS, potentially altering the course of patient treatment in real-time.

“Angiography is a suboptimal test to visualize the peripheral arteries. It underestimates vessel size, the presence and extent of calcium, thrombus and stenosis, and does not give a clear picture of optimal stent expansion and apposition. Moreover, the iDissection data confirms that angiography seriously underestimates the presence and severity of dissections following endovascular intervention,” commented  Dr. Nicolas W. Shammas, Founder and Research Director, Midwest Cardiovascular Research Foundation, Davenport, Iowa. “The iDissection study validates the need for more sophisticated imaging, such as IVUS, to evaluate acute procedural results.”

“We are very pleased with the results from the iDissection study and the expanding evidence incorporating IVUS as a useful tool to identify dissections often missed when using conventional angiography,” said Bruce Shook, Intact Vascular’s President and CEO. “The Tack Endovascular System® is specifically designed to repair dissections while leaving minimal metal in the artery, thereby reducing mechanical stress on the arterial wall and preserving future treatment options.”

Intact Vascular is sponsoring three clinical trials to evaluate its Tack Endovascular System: TOBA II, TOBA II BTK and TOBA III.  TOBA II is investigating the combination of the Tack implant with both plain angioplasty balloons and the BARD Lutonix® drug-coated balloon (DCB) in the arteries above the knee, and completed enrollment in March 2017. TOBA II BTK is investigating the combination of the Tack implant with plain balloon angioplasty in the arteries below the knee and is actively enrolling patients. TOBA III has completed enrollment in Europe and is investigating the combination of the Tack implant with the Medtronic IN.PACT™ Admiral™ (DCB), inclusive of long lesions.

About Intact Vascular

Intact Vascular is a privately held medical device company that develops minimally- invasive peripheral vascular products. The Tack Endovascular System is designed to improve peripheral balloon angioplasty results in the treatment of peripheral arterial disease. Visit www.intactvascular.com for more information.

This press release contains “forward-looking statements” concerning the development of Intact Vascular’s products, the potential benefits and attributes of such products, and the company’s expectations regarding its prospects. Forward-looking statements are subject to risks, assumptions and uncertainties that could cause actual future events or results to differ materially from such statements. These statements are made as of the date of this press release. Actual results may vary. Intact Vascular undertakes no obligation to update any forward-looking statements for any reason.

Contacts

Intact Vascular, Inc.
Andrea Dunkle, 1-484-253-1048

Tack Endovascular System® and Tack® are trademarks of Intact Vascular, Inc.
Lutonix® is a registered trademark of C.R.BARD, Inc.
IN.PACT(TM) Admiral(TM)  are trademarks of Medtronic, Inc.
“CAUTION: Investigational device. Limited by Federal (United States) law to investigational use.”
The Tack Endovascular System® is CE Mark Authorized under EC Directive 93/42/EEC.
Not available for sale or use in the United States.

Intact Vascular Sponsors Symposium on Post-Angioplasty Dissections Post-PTA dissection: clinical impact, identification and treatment

By | 2018 Press Releases, Press Releases

May 29, 2018 – WAYNE, Pa.–(BUSINESS WIRE)–Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today announced the schedule of key presentations that will be featured during a symposium sponsored together with Philips at the 19th Annual NCVH Conference in New Orleans on May 31.

Post-Percutaneous Transluminal Angioplasty (“PTA”) dissections are often overlooked, underdiagnosed and left untreated. These dissections can compromise clinical outcomes in both the short and long term. The use of intravascular ultrasound (“IVUS”) helps visualize the presence and severity of dissections not seen on angiography.

The Tack Endovascular System® is a new solution for precision dissection repair following balloon angioplasty with a first-of-its-kind implant that is designed to help maintain vessel integrity and enhance blood flow to promote healing, improve outcomes and preserve limbs. Unrepaired dissections — which are frequent following balloon angioplasty — increase the probability of acute arterial occlusion and may continue narrowing the artery, which leads to lower long-term patency rates. The Tack Endovascular System leaves a minimal amount of metal in the artery, reduces mechanical stress on the arterial wall and preserves future treatment options.

The co-sponsored symposium titled, “Post-PTA dissection: clinical impact, identification and treatment” will feature Ehrin Armstrong, MD, Nicolas Shammas, MD and George Adams, MD, and will include the following presentations:

  • Dissections matter: Evidence for post-PTA dissection, Ehrin Armstrong, MD
  • Dissection identification and classification using IVUS: The iDissection grading system, Nicolas Shammas, MD
  • Dissection repair with the Tack Endovascular System: Trial data, George Adams, MD

Notably, the iDissection identification and classification using IVUS presentation by Nicolas Shammas, MD will feature the recently completed study results from his iDissection pilot study. In the pilot study, 15 patients with femoropopliteal disease were treated with atherectomy and adjunctive PTA. Angiographic and IVUS images were obtained at baseline, post-atherectomy and post-angioplasty utlizing Philips ChromaFlo Imaging and evaluated for the presence and severity of dissections.

“Our mission at Intact Vascular is to make all forms of angioplasty more effective and durable. Identification of dissections and appropriate treatment is critical to maximize long term clinical success,” said Bruce Shook, Intact Vascular’s President and CEO. “We want to thank Philips for being a co-sponsor at NCVH to highlight the importance of IVUS to properly diagnose dissections often missed when using conventional angiography.”

Intact Vascular is sponsoring three clinical trials to evaluate its Tack Endovascular System: TOBA II, TOBA II BTK and TOBA III. TOBA II is investigating the combination of the Tack implant with both plain angioplasty balloons and the BARD Lutonix® drug-coated balloon (DCB) in the arteries above the knee, and completed enrollment in March 2017. TOBA II BTK is investigating the combination of the Tack implant with plain balloon angioplasty in the arteries below the knee and is actively enrolling patients. TOBA III has completed enrollment in Europe and is investigating the combination of the Tack implant with the Medtronic IN.PACT™ Admiral™ (DCB), inclusive of long lesions.

Visit https://www.intactvascular.com/clinical-trials/current-clinical-trials/ for more information on Intact Vascular’s robust clinical development program in the endovascular treatment of peripheral arterial disease and critical limb ischemia.

About Intact Vascular

Intact Vascular is a privately held medical device company that develops minimally- invasive peripheral vascular products. The Tack Endovascular System is designed to improve peripheral balloon angioplasty results in the treatment of peripheral arterial disease. Visit www.intactvascular.com for more information.

This press release contains “forward-looking statements” concerning the development of Intact Vascular’s products, the potential benefits and attributes of such products, and the company’s expectations regarding its prospects. Forward-looking statements are subject to risks, assumptions and uncertainties that could cause actual future events or results to differ materially from such statements. These statements are made as of the date of this press release. Actual results may vary. Intact Vascular undertakes no obligation to update any forward-looking statements for any reason.

Contacts

Intact Vascular, Inc.
Andrea Dunkle, 1-484-253-1048

Tack Endovascular System® and Tack® are trademarks of Intact Vascular, Inc.
Lutonix® is a registered trademark of C.R.BARD, Inc.
IN.PACT(TM) Admiral(TM) are trademarks of Medtronic, Inc.
“CAUTION: Investigational device. Limited by Federal (United States) law to investigational use.”
The Tack Endovascular System® is CE Mark Authorized under EC Directive 93/42/EEC.
Not available for sale or use in the United States.

Intact Vascular Announces Enrollment Completion of the Tack Optimized Balloon Angioplasty III (TOBA III) Clinical Trial

By | 2018 Press Releases, Press Releases

May 3, 2018 – WAYNE, Pa.–(BUSINESS WIRE)–Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today announced that its Tack Optimized Balloon Angioplasty III (TOBA III) clinical trial has completed enrollment. A total of 200 patients have been enrolled in TOBA III at 14 sites in Europe.

The TOBA III study is a prospective, multi-center, single-arm study designed to investigate the safety and efficacy of the Tack Endovascular System® in combination with the Medtronic IN.PACT™ Admiral™ drug-coated balloon (DCB) in the treatment of peripheral arterial disease (PAD) in the superficial femoral and popliteal arteries. The study includes a cohort of patients with long lesions, which are particularly challenging to treat successfully.

The Tack Endovascular System® is a new solution for precision dissection repair following balloon angioplasty with a first-of-its-kind implant that is designed to help maintain vessel integrity and enhance blood flow to promote healing, improve outcomes and preserve limbs. Unrepaired dissections — which are frequent following balloon angioplasty — increase the probability of acute arterial occlusion and may continue narrowing the artery, which leads to lower long-term patency rates. The Tack Endovascular System leaves a minimal amount of metal in the artery, reduces mechanical stress on the arterial wall and preserves future treatment options.

“Even in the era of drug-eluting technologies, post-angioplasty dissections continue to hinder long-term patency,” commented Professor Dr. Marianne Brodmann, Head of the Clinical Division of Angiology, Medical University Graz, Austria. “ I am encouraged that the Tack Endovascular System may provide durable, focal dissection repair using the least amount of metal and force in the artery.”

“Our mission at Intact Vascular is to make all forms of angioplasty more effective and durable. TOBA III seeks to accomplish that goal with the Medtronic DCB and in particularly challenging lesions,” said Bruce Shook, Intact Vascular’s President and CEO. “We want to thank our European investigators for their commitment to this important project and for completing study enrollment ahead of schedule.”

Intact Vascular is sponsoring two additional clinical trials to evaluate its Tack Endovascular System: TOBA II and TOBA II BTK. TOBA II is investigating the combination of the Tack device with both plain and drug-coated balloon angioplasty in the arteries above the knee, and completed enrollment in March 2017. TOBA II BTK is investigating the combination of the Tack device with plain balloon angioplasty in the arteries below the knee and is actively enrolling patients.

Visit https://www.intactvascular.com/clinical-trials/current-clinical-trials/ for more information on Intact Vascular’s robust clinical development program in the endovascular treatment of peripheral arterial disease and critical limb ischemia.

About Intact Vascular

Intact Vascular is a privately held medical device company that develops minimally- invasive peripheral vascular products. The Tack Endovascular System is designed to improve peripheral balloon angioplasty results in the treatment of peripheral arterial disease. Visit www.intactvascular.com for more information.

This press release contains “forward-looking statements” concerning the development of Intact Vascular’s products, the potential benefits and attributes of such products, and the company’s expectations regarding its prospects. Forward-looking statements are subject to risks, assumptions and uncertainties that could cause actual future events or results to differ materially from such statements. These statements are made as of the date of this press release. Actual results may vary. Intact Vascular undertakes no obligation to update any forward-looking statements for any reason.

Contacts

Intact Vascular, Inc.
Andrea Dunkle, 1-484-253-1048

Tack Endovascular System® and Tack® are trademarks of Intact Vascular, Inc.
Lutonix® is a registered trademark of C.R.BARD, Inc.
IN.PACT(TM) Admiral(TM)  are trademarks of Medtronic, Inc.
“CAUTION: Investigational device. Limited by Federal (United States) law to investigational use.”
The Tack Endovascular System® is CE Mark Authorized under EC Directive 93/42/EEC.
Not available for sale or use in the United States.

Intact Vascular Announces $20 Million Series C Financing to Fund Company through PMA Approval of the Tack Endovascular System®

By | 2018 Press Releases, Press Releases

April 16, 2018 – WAYNE, Pa.–(BUSINESS WIRE)–Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today announced that it closed a Series C financing totaling $20 million. This financing is designed to fund the Company through Pre-Market Approval (“PMA”) of the Tack Endovascular System for the treatment of post-angioplasty dissections above the knee.

Major participants in the Series C financing included New Enterprise Associates (“NEA”), H.I.G. BioVentures and Quaker Partners. The financing is structured in two stages or tranches, with the second tranche closing later in 2018.

“We continue to be impressed with the extensive clinical program that Intact Vascular is advancing to illustrate the significant clinical benefits that a better solution for dissections can have on angioplasty for peripheral arterial disease and critical limb ischemia,” said Justin Klein, MD, JD, Partner at New Enterprise Associates and member of the Intact Vascular Board of Directors. “NEA is proud to partner with the Intact team, the world class group of TOBA trial series investigators, and our other investing partners to advance the Tack® through its pivotal trials and launch as a global commercial growth opportunity.”

The Tack Endovascular System is a new solution for precision dissection repair following balloon angioplasty with a first-of-its-kind implant that is designed to help maintain vessel integrity and enhance blood flow to promote healing, improve outcomes and preserve limbs. Unrepaired dissections — which are frequent following balloon angioplasty — increase the probability of acute arterial occlusion and may continue narrowing the artery, which leads to lower long-term patency rates. The Tack Endovascular System leaves a minimal amount of metal in the artery, reduces mechanical stress on the arterial wall and preserves future treatment options.

“We are at an exciting inflection point in the development of the Tack Endovascular System. With the projected completion of primary endpoint analysis for our pivotal TOBA II trial, and the projected completion of enrollment in both TOBA II BTK and TOBA III, 2018 is a true watershed year for us,” said Bruce Shook, Intact Vascular’s President and CEO. “We are delighted to partner with NEA, H.I.G., Quaker and several other investors on our journey to improve the treatment of peripheral arterial disease, and we truly appreciate their continued vote of confidence.”

Intact Vascular is sponsoring three clinical trials to evaluate its Tack Endovascular System: TOBA II, TOBA III and TOBA II BTK. TOBA II is investigating the combination of the Tack device with both plain and BARD Lutonix® drug-coated balloon (“DCB”) angioplasty in the arteries above the knee, and completed enrollment in March 2017. TOBA III is investigating the combination of the Tack system with the Medtronic IN.PACT™ Admiral™ DCB in the arteries above the knee (inclusive of long lesions), and is nearing full enrollment, and TOBA II BTK is investigating the combination of the Tack device with plain balloon angioplasty in the arteries below the knee and is actively enrolling patients.

Visit www.intactvascular.com for more information on the Tack Endovascular System and Intact Vascular’s robust clinical development program in the endovascular treatment of peripheral arterial disease and critical limb ischemia.

About Intact Vascular

Intact Vascular is a privately held medical device company that develops minimally- invasive peripheral vascular products. The Tack Endovascular System is designed to improve peripheral balloon angioplasty results in the treatment of peripheral arterial disease. Visit www.intactvascular.com for more information.

This press release contains “forward-looking statements” concerning the development of Intact Vascular’s products, the potential benefits and attributes of such products, and the company’s expectations regarding its prospects. Forward-looking statements are subject to risks, assumptions and uncertainties that could cause actual future events or results to differ materially from such statements. These statements are made as of the date of this press release. Actual results may vary. Intact Vascular undertakes no obligation to update any forward-looking statements for any reason.

Contacts

Intact Vascular, Inc.
Andrea Dunkle, 1-484-253-1048

Tack Endovascular System® and Tack® are trademarks of Intact Vascular, Inc.
Lutonix® is a registered trademark of C.R.BARD, Inc.
IN.PACT(TM) Admiral(TM)  are trademarks of Medtronic, Inc.
“CAUTION: Investigational device. Limited by Federal (United States) law to investigational use.”
The Tack Endovascular System® is CE Mark Authorized under EC Directive 93/42/EEC.
Not available for sale or use in the United States.

 

Intact Vascular Welcomes TOBA BTK Trial One-Year Clinical Study Results Publication in Catheterization and Cardiovascular Intervention

By | 2018 Press Releases, Press Releases

March 27, 2018 – WAYNE, Pa.–(BUSINESS WIRE)–Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today welcomed the publication of the Tack Optimized Balloon Angioplasty Below the Knee (TOBA BTK) clinical trial results in the current issue of Catheterization and Cardiovascular Intervention.

This multi-center pilot study focused on collecting data supporting the safety and performance of the Tack Endovascular System® in subjects with Critical Limb Ischemia (CLI) due to vascular disease below the knee. Thirty-five subjects were enrolled at six sites in Europe and New Zealand in the TOBA BTK study, which targeted diseased tibial arteries for dissection repair following plain balloon angioplasty.

The analysis of the TOBA BTK data demonstrates one-year primary patency via Kaplan-Meier estimate of 77.4%. Additionally:

  • 93.5% freedom from Clinically Driven Target Lesion Revascularization (CD-TLR)
  • 93.5% freedom from Clinically Driven Target Vessel Revascularization (CD-TVR)
  • 84.5% amputation-free survival (AFS).

“The number of patients being treated for critical limb ischemia is rapidly growing, making it vitally important to optimize post-angioplasty results and minimize metal burden to improve blood flow and allow wound healing,” commented Professor Dr. Marianne Brodmann, Head of the Clinical Division of Angiology, Medical University Graz, Austria. “I believe that the Tack Endovascular System provides a promising option to treat post-angioplasty dissection in this very challenging patient population.”

The TOBA BTK multi-center pilot study was the first known industry-sponsored study designed to investigate a permanent vascular implant in arteries below the knee for 2 focal dissection repair. The Tack® implant is a first-of-its kind device for precision dissection repair following balloon angioplasty. The system is designed to help maintain vessel integrity and improve blood flow to promote healing, improve outcomes and preserve limbs. The system leaves a minimal amount of metal in the artery, reduces mechanical stress on the arterial wall and preserves future treatment options. Unrepaired dissections — which are frequent following balloon angioplasty — increase the probability of acute arterial occlusion and may continue narrowing the artery, which leads to lower long-term patency rates.

“We are very pleased with the results from the TOBA BTK study and the expanding publication of peer-reviewed clinical evidence supporting the Tack Endovascular System,” said Bruce Shook, Intact Vascular’s President and CEO. “As we previously reported, we are on track to complete our pivotal TOBA II BTK clinical study enrollment earlier than originally planned, and we are thankful to our committed investigators who are eager to have more approved therapeutic options to treat their patients with CLI.”

Intact Vascular is sponsoring three clinical trials to evaluate its Tack Endovascular System: TOBA II, TOBA II BTK and TOBA III. TOBA II is investigating the combination of the Tack device with both plain and drug-coated balloon angioplasty in the arteries above the knee, and completed enrollment in March 2017. TOBA II BTK is investigating the combination of the Tack device with plain balloon angioplasty in the arteries below the knee and is actively enrolling patients. TOBA III has nearly completed enrollment in Europe and is investigating the combination of the Tack device with drug-coated balloon angioplasty, inclusive of long lesions.

Visit https://www.intactvascular.com/clinical-trials/current-clinical-trials/ for more information on Intact Vascular’s robust clinical development program in the endovascular treatment of peripheral arterial disease.

About Intact Vascular

Intact Vascular is a privately held medical device company that develops minimally invasive peripheral vascular products. The Tack Endovascular System is designed to optimize peripheral balloon angioplasty results in the treatment of peripheral arterial disease. Visit www.intactvascular.com for more information.

This press release contains “forward-looking statements” concerning the development of Intact Vascular’s products, the potential benefits and attributes of such products, and the company’s expectations regarding its prospects. Forward-looking statements are subject to risks, assumptions and uncertainties that could cause actual future events or results to differ materially from such statements. These statements are made as of the date of this press release. Actual results may vary. Intact Vascular undertakes no obligation to update any forward-looking statements for any reason.

Contacts

Intact Vascular, Inc.
Andrea Dunkle, 1-484-253-1048
adunkle@intactvascular.com

Tack Endovascular System® and Tack® are trademarks of Intact Vascular, Inc.

“CAUTION: Investigational device. Limited by Federal (United States) law to investigational use.”
The Tack Endovascular System® is CE Mark Authorized under EC Directive 93/42/EEC.
Not available for sale or use in the United States

TOBA II BTK Trial Enrollment Ahead Of Schedule For The Tack Endovascular System® In Below The Knee Disease

By | 2018 Press Releases, Press Releases

January 25, 2018 – WAYNE, Pa.–(BUSINESS WIRE)–Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today announced the Tack Optimized Balloon Angioplasty II Below the Knee (TOBA II BTK) clinical trial surpassed the 100 patient milestone, advancing enrollment well ahead of schedule.

The TOBA II BTK is a prospective, multi-center, single-arm study designed to investigate the safety and efficacy of the Tack Endovascular System in combination with standard balloon angioplasty in the mid/distal popliteal, tibial and peroneal arteries during the treatment of critical limb ischemia (CLI) patients. The Tack implant is a first-of-its kind device for precision dissection repair following balloon angioplasty. The system is designed to help maintain vessel integrity and improve blood flow to promote healing, improve outcomes and preserve limbs. The system leaves a minimal amount of metal in the artery, reduces mechanical stress on the arterial wall and preserves future treatment options. Unrepaired dissections — which are frequent following balloon angioplasty — increase the probability of acute arterial occlusion and may continue narrowing the artery, which leads to lower long-term patency rates. TOBA II BTK is the first known industry sponsored pivotal clinical trial approved by the US Food and Drug Administration to investigate a permanent vascular implant in arteries below the knee.

“We are very pleased to be making excellent progress in this important study as we exceeded the 100thpatient milestone,” said Bruce Shook, Intact Vascular’s President and CEO. “We are on track to complete enrollment earlier than originally planned, and we are thankful to our committed investigators who are eager to have more approved therapeutic options to treat their patients with CLI.”

Intact Vascular is sponsoring three clinical trials to evaluate its Tack Endovascular System: TOBA II, TOBA II BTK and TOBA III.  TOBA II is investigating the combination of the Tack device with both plain and drug-coated balloon angioplasty in the arteries above the knee, and completed enrollment in February 2017. TOBA II BTK is investigating the combination of the Tack device with plain balloon angioplasty in the arteries below the knee and is actively enrolling patients. TOBA III has nearly completed enrollment in Europe and is investigating the combination of the Tack device with drug-coated balloon angioplasty, inclusive of long lesions.

Visit https://www.intactvascular.com/clinical-trials/current-clinical-trials/ for more information on Intact Vascular’s robust clinical development program in the endovascular treatment of peripheral arterial disease.

About Intact Vascular

Intact Vascular is a privately held medical device company that develops minimally invasive peripheral vascular products. The Tack Endovascular System is designed to optimize peripheral balloon angioplasty results in the treatment of peripheral arterial disease. Visit www.intactvascular.com for more information.

This press release contains “forward-looking statements” concerning the development of Intact Vascular’s products, the potential benefits and attributes of such products, and the company’s expectations regarding its prospects. Forward-looking statements are subject to risks, assumptions and uncertainties that could cause actual future events or results to differ materially from such statements. These statements are made as of the date of this press release. Actual results may vary. Intact Vascular undertakes no obligation to update any forward-looking statements for any reason.

Contacts

Intact Vascular, Inc.
Andrea Dunkle, 1-484-253-1048
adunkle@intactvascular.com

Tack Endovascular System® and Tack® are trademarks of Intact Vascular, Inc.

“CAUTION: Investigational device. Limited by Federal (United States) law to investigational use.”
The Tack Endovascular System® is CE Mark Authorized under EC Directive 93/42/EEC.
Not available for sale or use in the United States

Positive Twenty-Four Month Tack Optimized Balloon Angioplasty (“TOBA”) Single Center Results Presented at VEITHsymposium™ Conference

By | 2017 Press Releases, Press Releases

November 16, 2017 – WAYNE, Pa.–(BUSINESS WIRE)–Intact Vascular, Inc., a developer of medical devices for minimally-invasive peripheral vascular procedures, today announced that positive single center twenty-four month results from its Tack Optimized Balloon Angioplasty (TOBA) clinical study were presented at the VEITHsymposium™ 2017 conference by Dr. Christian Wissgott, Assistant Director, at Westküstenklinikum Heide in Heide, Germany. The TOBA study enrolled 138 subjects at 13 sites in Europe. All study participants were suffering from peripheral artery disease caused by blockages in the superficial femoral or popliteal arteries, located in the upper part of the leg. All participants underwent percutaneous balloon angioplasty (“PTA”) and repair of any dissections (or tears) resulting from PTA using the Tack Endovascular System®.

The Tack® implant is a first-of-its kind device for precision dissection repair following balloon angioplasty. The Tack Endovascular System is designed to help maintain vessel integrity and maximize blood flow to promote healing, improve outcomes and save limbs. The system leaves a minimal amount of metal in the artery, reduces mechanical stress on the arterial wall and preserves future treatment options. Unrepaired dissections—which are frequent following PTA procedures—increase the probability of acute arterial occlusion and may continue narrowing the artery, which leads to lower long-term patency (or openness) rates.

Dr. Wissgott’s single center twenty-four month Kaplan-Meier patency results were unchanged from the favorable twelve-month rate of 87.5%. “The Tack implant offers a new paradigm for focal dissection repair in the superficial femoral or popliteal arteries,” Wissgott said. “Zero reduction in vessel patency over twelve months appears to be attributable to the Tack design, which leaves 70-80% less metal behind when compared to traditional stents. In addition, the Tack’s lower chronic outward force minimizes vessel inflammation and reduces vessel trauma that can contribute to restenosis.”

“We are very pleased with Dr. Wissgott’s twenty-four month single center results from our TOBA study,” said Bruce Shook, Intact Vascular’s President and CEO. “Dr. Wissgott’s results illustrate the potential for improvement of long-term patency following angioplasty with precision dissection repair using the Tack Endovascular System.”

Intact Vascular is sponsoring three clinical trials to evaluate its Tack Endovascular System: TOBA II, TOBA II BTK and TOBA III.  TOBA II is investigating the combination of the Tack device with both plain and drug-coated balloon angioplasty in the arteries above the knee, and completed enrollment in February 2017. TOBA II BTK is investigating the combination of the Tack device with plain balloon angioplasty in the arteries below the knee and is actively enrolling patients. TOBA III is currently underway in Europe and is investigating the combination of the Tack device with drug-coated balloon angioplasty; enrollment is nearly complete.

Visit https://www.intactvascular.com/clinical-trials/current-clinical-trials/ for more information on Intact Vascular’s robust clinical development program in the endovascular treatment of peripheral arterial disease.

About Intact Vascular

Intact Vascular is a privately held medical device company that develops minimally invasive peripheral vascular products. The Tack Endovascular System is designed to optimize peripheral balloon angioplasty results in the treatment of peripheral arterial disease. Visit www.intactvascular.com for more information.

This press release contains “forward-looking statements” concerning the development of Intact Vascular’s products, the potential benefits and attributes of such products, and the company’s expectations regarding its prospects. Forward-looking statements are subject to risks, assumptions and uncertainties that could cause actual future events or results to differ materially from such statements. These statements are made as of the date of this press release. Actual results may vary. Intact Vascular undertakes no obligation to update any forward-looking statements for any reason.

Contacts

Intact Vascular, Inc.
Andrea Dunkle, 1-484-253-1048
adunkle@intactvascular.com

Tack Endovascular System® and Tack® are trademarks of Intact Vascular, Inc.

“CAUTION: Investigational device. Limited by Federal (United States) law to investigational use.”
The Tack Endovascular System® is CE Mark Authorized under EC Directive 93/42/EEC.
Not available for sale or use in the United States

Intact Vascular Announces Enrollment of First European Patient in Tack Optimized Balloon Angioplasty II Below the Knee (TOBA II BTK) Clinical Trial with the Tack Endovascular System®

By | 2017 Press Releases, Press Releases

July 18, 2017 – WAYNE, Pa.–(BUSINESS WIRE)–Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today announced that its Tack Optimized Balloon Angioplasty II Below the Knee (TOBA II BTK) clinical trial has commenced enrollment in Europe, with the first patient treated by Professor Dr. Marianne Brodmann and Dr. Peter Reif at Medical University Graz, Austria.

The TOBA II BTK study, which enrolled its first patient in February 2017, is a prospective, multi-center, single-arm study designed to investigate the safety and efficacy of the Tack Endovascular System in combination with standard balloon angioplasty in the popliteal and tibial arteries for the treatment of critical limb ischemia (CLI). The Tack Endovascular System is a new technology designed to repair dissections (or tears) in the artery wall that frequently occur as a complication of balloon angioplasty. The system is intended to provide physicians with an alternative for repair of dissections while leaving a minimal amount of foreign material in the artery, which reduces mechanical stress on the artery and preserves future treatment options. We believe TOBA II BTK is the first industry sponsored pivotal clinical trial approved by the US Food and Drug Administration to investigate a permanent vascular implant in arteries below the knee.

“We are pleased to be the first center in Europe to commence enrollment in TOBA II BTK,” commented Professor Dr. Marianne Brodmann, Head of the Clinical Division of Angiology, Medical University Graz, Austria. “I believe the Tack Endovascular System is a very promising technology designed to optimize dissection repair while leaving a minimal metal footprint behind post-implantation.”

The TOBA II BTK study will be conducted at up to 50 global sites and will enroll 232 patients in total. Eligible patients will have diseased popliteal or tibial arteries treated with balloon angioplasty and have a dissection in the artery wall immediately following angioplasty.

“The spiral dissection we treated in this first patient was ideally suited for the Tack Endovascular System since it is the only device uniquely designed to treat below-the-knee dissections following angioplasty,” stated Dr. Peter Rief.

“Critical limb ischemia (CLI) is a serious disease that all too often leads to amputation. It is vital that we develop new technologies to restore and maintain blood flow to the lower leg and foot. I am pleased that we have commenced enrolling patients in European centers,” said Dr. Andrej Schmidt, Division of Interventional Angiology, University Hospital Leipzig, Germany and European Principal Investigator for the TOBA II BTK clinical trial. “The Tack Endovascular System represents a major step forward in the endovascular treatment of CLI.”

Intact Vascular is sponsoring three clinical trials to evaluate its Tack Endovascular System: TOBA II, TOBA II BTK and TOBA III. TOBA II is investigating the combination of the Tack® device with both plain and drug-coated balloon angioplasty in the arteries above the knee. TOBA II BTK is investigating the combination of the Tack device with plain balloon angioplasty in the arteries below the knee. TOBA III is currently underway in Europe and is investigating the combination of the Tack Endovascular System with drug-coated balloon angioplasty. Visit https://www.intactvascular.com/actively-enrolling for more information on Intact Vascular’s robust clinical development program in the endovascular treatment of peripheral arterial disease.

About Intact Vascular
Intact Vascular is a privately held medical device company that develops minimally invasive peripheral vascular products. The Tack Endovascular System is designed to optimize peripheral balloon angioplasty results in the treatment of peripheral arterial disease. Visit www.intactvascular.com for more information.

This press release contains “forward-looking statements” concerning the development of Intact Vascular’s products, the potential benefits and attributes of such products, and the company’s expectations regarding its prospects. Forward-looking statements are subject to risks, assumptions and uncertainties that could cause actual future events or results to differ materially from such statements. These statements are made as of the date of this press release. Actual results may vary. Intact Vascular undertakes no obligation to update any forward-looking statements for any reason.

Contacts
Intact Vascular, Inc.
Andrea Dunkle, 1-484-253-1048
adunkle@intactvascular.com

Tack Endovascular System® and Tack® are trademarks of Intact Vascular, Inc.

“CAUTION: Investigational device. Limited by Federal (United States) law to investigational use.”
The Tack Endovascular System® is CE Mark Authorized under EC Directive 93/42/EEC.
Not available for sale or use in the United States