Category

Press Releases

Intact Vascular Announces Presentations at LINC 2019 Annual Meeting

By | 2018 Press Releases, Press Releases

Presentations Showcase the Importance of Treating Post-Angioplasty Dissections 

January 14, 2019 – WAYNE, Pa.–(BUSINESS WIRE)–Intact Vascular, Inc., a private medical device company committed to developing solutions for minimally invasive peripheral vascular procedures, today announced the schedule of key presentations to be featured at the annual Leipzig Interventional Course (LINC) in Leipzig, Germany on Tuesday, January 22nd and Wednesday, January 23rd.

Intact Vascular’s Tack Endovascular System® is a first-of-its-kind dissection repair device implanted following post-angioplasty dissections in patients with peripheral arterial disease (PAD) and critical limb ischemia (CLI). Patients often suffer from dissections that are frequently overlooked, undiagnosed and untreated. If untreated, these dissections can compromise clinical outcomes, resulting in acute thrombosis and arterial occlusions, leading to lower long-term patency rates and repeat procedures.

“We are pleased that the topic of post-angioplasty dissections is prominently highlighted this year at the LINC meeting,” stated Bruce Shook, President and CEO of Intact Vascular. “We are excited to share the robust clinical program for Intact’s Tack Endovascular System and demonstrate how our technology improves outcomes for patients.”

The following sessions will be presented on Tuesday, January 22nd: 

1:00 – 1:05 (Main Arena – Room 1): TOBA II Trial: 1-Year Results, presented by William Gray, MD

1:35 – 1:40 (Technical Forum – Room 3): Dissecting the TOBA Data: What Does it Mean in Practice, presented by Peter Schneider, MD

Additionally, the following sessions will be presented on Wednesday, January 23rd in the Global Expert Exchange Forum (Room 5):

11:20 – 11:25: Dissections Matter: Evidence for Post-PTA Dissections, presented by Ehrin Armstrong, MD

11:25 – 11:30: Dissection Identification and Classification Using IVUS, presented by Nicolas Shammas, MD

11:30 – 11:35: How I Will Use the Tack Endovascular System® in the Real World, presented by Michael Lichtenberg, MD

Visit the Intact Vascular booth, #41, to learn more about the Tack Endovascular System.

About Intact Vascular and the Tack Endovascular System

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. Pre-loaded with six self-expanding nitinol devices for above-the-knee (ATK) interventions, the Tack Endovascular System can be deployed to treat multiple dissections using a single catheter and leaving behind >70% less metal than stents1. Additionally, the Tack Endovascular System is designed to minimize vessel inflammation, promote healing, improve outcomes and preserve future treatment options for PAD and critical limb ischemia (CLI) patients. Visit www.intactvascular.com for more information.

Intact Vascular Clinical Program

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 plain angioplasty balloons and the BARD Lutonix® drug-coated balloon (DCB) in arteries above the knee and has completed its primary endpoint analysis. TOBA II BTK is investigating the combination of the Tack implant with plain balloon angioplasty in the arteries below the knee and has recently completed enrollment. 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.

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 Launch of the Tack Endovascular System® in the EU and First Commercial Use in Germany

By | 2018 Press Releases, Press Releases

January 7, 2019 – WAYNE, Pa.–(BUSINESS WIRE)–Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today announced the first commercial use of its Tack Endovascular System® in multiple hospitals within Germany. A novel therapy for dissection repair following balloon angioplasty, the Tack® implant is a first-of-its kind device for patients with peripheral arterial disease (PAD) and/or critical limb ischemia (CLI).

“The Tack System provides a much needed therapeutic option for treating dissections in the superficial femoral or popliteal arteries following balloon angioplasty,” said Dr. Christian Wissgott, Assistant Director, at Westküstenklinikum Heide in Heide, Germany. “I am very pleased with my experience using the implant and I am excited to incorporate this technology into my above and below the knee treatment algorithms going forward.”

Patients treated with balloon angioplasty frequently suffer from dissections. Often overlooked, undiagnosed and untreated, dissections can lead to acute thrombosis and arterial occlusions, which lower long-term patency rates and require repeat procedures. Designed to resolve these dissections while leaving minimal metal behind, the Tack implant is uniquely designed to preserve vessel integrity, minimize vessel inflammation and enhance blood flow.

“With the Tack System, balloon angioplasty results are improved regardless if it is drug-eluting or not,” noted Dr. Michael K.W. Lichtenberg, Chief of Angiology Clinic and Venous Center, Klinikum Arnsberg in Germany. “Based on my initial experience, I am confident this new paradigm of focal dissection repair will become standard of care for patients undergoing PAD interventions.”

“Commercializing the Tack Endovascular System is a major achievement for our company and ultimately for patients undergoing balloon angioplasty,” stated Howard Rosen, Vice President of Marketing & Business Development at Intact Vascular. “We are excited to bring this impactful technology to market and look forward to expanding our commercial efforts in Europe.”

 

About Intact Vascular and the Tack Endovascular System

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. Pre-loaded with six self-expanding nitinol devices for above-the-knee (ATK) or four for below-the-knee (BTK) interventions, the Tack Endovascular System can be deployed to treat multiple dissections using a single catheter and leaving behind >70% less metal than stents1. Additionally, the Tack Endovascular System is designed to minimize vessel inflammation, promote healing, improve outcomes and preserve future treatment options for PAD and critical limb ischemia (CLI) patients. Visit www.intactvascular.com for more information.

Intact Vascular Clinical Program

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 plain angioplasty balloons and the BARD Lutonix® drug-coated balloon (DCB) in arteries above the knee and has completed its primary endpoint analysis. TOBA II BTK is investigating the combination of the Tack implant with plain balloon angioplasty in the arteries below the knee and has completed enrollment. 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.

This press release contains “forward-looking statements” concerning the development of Intact Vascular’s products, the 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

1Bosiers M, Scheinert D, Hendricks JMH et al. Results from the Tack Optimized Balloon Angioplasty (TOBA) study demonstrate the benefits of minimal metal implants for dissection repair after angioplasty. J Vasc Surg 2016;64:109-16.

CAUTION: Investigational device. Limited by Federal (United States) law to investigational use.”
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.
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 TOBA II BTK Clinical

By | 2018 Press Releases, Press Releases

First-of-its-kind study designed to demonstrate safety and efficacy of the Tack Endovascular System® in treating post-PTA dissections below the knee. January 2, 2019 – WAYNE, Pa.–(BUSINESS WIRE)–Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today announced its Tack Optimized Balloon Angioplasty II BTK (TOBA II BTK) clinical trial successfully completed enrollment, ahead of schedule.

Read More

Intact Vascular to Sponsor Post-Angioplasty Dissection Symposium and Present an Update on the TOBA II Pivotal Study Results at the 2018 VEITH Conference

By | 2018 Press Releases, Press Releases

November 12, 2018 – WAYNE, Pa.–(BUSINESS WIRE)–Intact Vascular, Inc., a private medical device company committed to developing solutions for minimally invasive peripheral vascular procedures, today announced the schedule of key presentations to be featured during a lunch symposium co-sponsored with Philips at the 45th annual VEITH conference in New York City on Thursday, November 15th. Following the symposium, an update on the company’s TOBA II pivotal trial will be presented.

Intact Vascular’s Tack Endovascular System®, a first-of-its-kind dissection repair device, is designed to preserve vessel integrity and enhance blood flow following balloon angioplasty. Patients with peripheral arterial disease (PAD) who are treated with balloon angioplasty often suffer from dissections or tears that are frequently overlooked, undiagnosed and untreated. These dissections can compromise clinical outcomes, resulting in acute thrombosis and arterial occlusions, leading to lower long-term patency rates and repeat procedures. Research has shown that intravascular ultrasound (IVUS) helps to visualize these dissections, confirming their presence and severity, often not visualized on traditional angiography1.

“The clinical impact of post-angioplasty dissections, although often under-diagnosed and under-estimated, is in fact substantial and can lead to high rates of restenosis and re-intervention,” said Bruce Shook, President and CEO of Intact Vascular. “Our symposium highlights the importance of IVUS to assist in the diagnosis of dissections and the clinical significance of the Tack Endovascular System to minimize further complications and improve the frequently painful, debilitating symptoms for these patients.”

The co-sponsored lunch symposium, “Leave no dissection behind; improve what you see, repair with precision”, will be held from 12:30-1:30PM in the Gramercy Suite West, New York Hilton Midtown and will include the following presentations:

·         Dissections matter and they matter even more in the DCB era: Evidence above and below the knee – presented by Ehrin Armstrong, MD

·         iDissection: using IVUS to see what we are missing: iDissection classification system using intravascular imaging – presented by Nicolas Shammas, MD

·         Tack optimized angioplasty: results from TOBA II: Twelve-month pivotal trial results – presented by William Gray, MD

·         Precision dissection repair: European experience with the Tack Endovascular System® – presented by Michael Lichtenberg, MD

Following the lunch symposium, Dr. Marianne Brodmann from the Medical University of Graz in Austria, will present Update on the Value of Tack Assisted Balloon Angioplasty: Results of the TOBA II Study: Do the Tacks Improve PTA Patency In The Femoropopliteal Segment? from 2:40-2:45PM in the Grand Ballroom West, 3rd Floor.

The Tack Endovascular System will be on display at Intact Vascular’s exhibitor booth, #215.

About Intact Vascular and the Tack Endovascular System

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. Pre-loaded with six self-expanding nitinol devices for above-the-knee (ATK) interventions, the Tack Endovascular System can be deployed to treat multiple dissections using a single catheter and leaving behind >70% less metal than stents2. Additionally, the Tack Endovascular System offers low radial force, designed to promote healing, improve outcomes and preserve future treatment options for PAD and critical limb ischemia (CLI) patients. Visit www.intactvascular.com for more information.

Intact Vascular Clinical Program

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 plain angioplasty balloons and the BARD Lutonix® drug-coated balloon (DCB) in arteries above the knee. 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.

This press release contains “forward-looking statements” concerning the development of Intact Vascular’s products, the potential benefits and attributes of such products and technologies with which its products can be used, 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

1Shammas, NW, Torey, JT, Shammas, WJ, et al. Intravascular Ultrasound Assessment and Correlation With Angiographic Findings Demonstrating Femoropopliteal Arterial Dissections Post Atherectomy: Results From the iDissection Study. J Invas Cardio 2018; 30:240-244.

 2Bosiers M, Scheinert D, Hendricks JMH et al. Results from the Tack Optimized Balloon Angioplasty (TOBA) study demonstrate the benefits of minimal metal implants for dissection repair after angioplasty. J Vasc Surg 2016;64:109-16.

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

y 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 Positive One-Year Data from the TOBA II Clinical Trial

By | 2018 Press Releases, Press Releases

First-of-its-kind study designed to demonstrate safety and efficacy of the Tack Endovascular System® in treating post-PTA dissections 

November 6, 2018 – WAYNE, Pa.–(BUSINESS WIRE)–Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today announced at the 15th annual VIVA conference in Las Vegas that its Tack Optimized Balloon Angioplasty II (TOBA II) clinical trial successfully achieved both primary and secondary endpoints.  One year results from the TOBA II study were presented in the late-breaking scientific session by William Gray, M.D., System Chief, Division of Cardiovascular Disease at Main Line Health, President, Lankenau Heart Institute and Principal Investigator for the TOBA II trial.

Notably the first peripheral vascular study to enroll patients with 100% dissected vessels, the TOBA II study, was conducted at 33 U.S. and European sites to investigate the Tack Endovascular System for the repair of post-angioplasty dissections in femoropopliteal arteries. All patients enrolled (n=213) suffered from peripheral arterial disease (PAD), underwent balloon angioplasty with either plain or drug-coated balloons, and consequently experienced at least one dissection, with 69.4% being classified as severe.

Impressive results presented from this first-of-its-kind study demonstrated 92.1% complete dissection resolution within a clinically challenging patient population, along with 79.3% K-M vessel patency and 86.5% K-M freedom from clinically driven reintervention at 12-months. Additionally, the TOBA II study validated the Tack® implants as stable and durable, with zero implant fractures, 99.9% freedom from migration, and a 0.5% bailout stent rate.

“The TOBA II study is unique in that it is the first large scale pivotal evaluation in peripheral arterial vessels that are 100% dissected following initial angioplasty and treated with a precisely targeted implant,” commented Dr. William Gray. “This study introduces a new therapeutic paradigm, demonstrating that we can repair dissected arteries, leaving minimal metal behind to preserve future treatment options for our patients, and producing excellent 12-month outcomes.”

“As presented today, the TOBA II data further augment the growing body of evidence supporting the idea that a purpose-built implant for dissection repair can enhance the clinical results of balloon angioplasty,” said Bruce Shook, Intact Vascular’s President and CEO. “The Tack Endovascular System is also well aligned with a primary goal of endovascular operators: to leave as little metal behind as possible.”

About Intact Vascular and the Tack Endovascular System

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. Pre-loaded with six self-expanding nitinol devices for above-the-knee (ATK) interventions, the Tack Endovascular System can be deployed to treat multiple dissections using a single catheter and leaving behind >70% less metal than stents1. Additionally, the Tack Endovascular System offers low radial force, designed to promote healing, improve outcomes and preserve future treatment options for PAD and critical limb ischemia (CLI) patients. Visit www.intactvascular.com for more information.

Intact Vascular Clinical Program

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 plain angioplasty balloons and the BARD Lutonix® drug-coated balloon (DCB) in arteries above the knee. 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.

This press release contains “forward-looking statements” concerning the development of Intact Vascular’s products, the 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

1Bosiers M, Scheinert D, Hendricks JMH et al. Results from the Tack Optimized Balloon Angioplasty (TOBA) study demonstrate the benefits of minimal metal implants for dissection repair after angioplasty. J Vasc Surg 2016;64:109-16.

Intact Vascular Hires Industry Veteran Steve MacKinnon as Vice President of Sales

By | 2018 Press Releases, Press Releases

November 5, 2018 – WAYNE, Pa.–(BUSINESS WIRE)– Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today announced that Steve MacKinnon has joined its senior management team as Vice President of Sales, effective immediately. Reporting to the CEO, Mr. MacKinnon will oversee the creation of a U.S. based sales team and will play a central role in planning and executing the company’s projected launch of the Tack Endovascular System® in 2019.

Read More

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 …

Read More

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.