Category

2016 Press Releases

FDA Approves TOBA II BTK Pivotal IDE Clinical Study

By | 2016 Press Releases, Press Releases

October 31, 2016 – WAYNE, Pa.–(BUSINESS WIRE)–Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today announced that the U.S. Food and Drug Administration (FDA) granted staged approval for the Company’s Investigational Device Exemption (IDE) application to begin its Tack Optimized Balloon Angioplasty II BTK (“TOBA II BTK”) clinical study. The study will examine the safety and efficacy of the Tack Endovascular System when used to repair dissections (or tears) in the arteries below the knee (BTK) following percutaneous transluminal angioplasty (PTA) as a treatment for critical limb ischemia (CLI).

Patrick J. Geraghty, M.D., Professor of Surgery and Radiology at the Washington University School of Medicine of St. Louis, and George Adams, M.D., M.H.S., Director of Cardiovascular and Peripheral Vascular Research, UNC REX Hospital, Raleigh, N.C., are national Principal Investigators for the study. Doctors Geraghty and Adams bring a wealth of experience with the endovascular treatment of peripheral artery disease and with the design and conduct of clinical trials for endovascular therapies.

The TOBA II BTK study is designed to enroll 232 subjects at up to a total of 50 U.S. and international sites. Patients experiencing symptoms from advanced peripheral artery disease below the knee will be eligible. Frequently termed CLI, this condition often results in severe disability including pain, chronic wounds, gangrene and amputation. Study subjects will be treated with the Tack Endovascular System following standard balloon angioplasty in the popliteal or tibial arteries when a dissection occurs.

Bruce J. Shook, President and CEO at Intact Vascular, stated, “The TOBA II BTK clinical study represents an exciting opportunity to bring the first vascular implant to the U.S. market for the treatment of critical limb ischemia patients. We are thrilled with the level of enthusiasm from the clinical community and look forward to collaborating with them on this important advancement for CLI care.”

In July 2016, promising 12-month results from the TOBA study, which examined use of the Tack® implant to treat dissections above the knee, were published in the Journal of Vascular Surgery1. The 12-month results from the TOBA BTK pilot study also were released last May at the Society for Cardiac Angiography and Interventions (SCAI) 2016 Annual Meeting2. Both of these studies demonstrated the potential of the Tack implant to improve arterial healing following angioplasty above and below the knee.

Dr. Geraghty stated, “Critical limb ischemia is a debilitating condition for many patients with serious downstream consequences such as amputation and loss of independence. The disease is growing rapidly, especially with the increasing incidence of diabetes, creating an urgent need for more effective treatments. The TOBA II BTK study represents an exciting opportunity to improve the long-term results associated with angioplasty, which is our primary, minimally invasive treatment for CLI. This study is the first pivotal trial ever conducted in the U.S. supporting the FDA approval of an implantable device for CLI treatment.”

Dr. Adams added, “We are very enthusiastic about the commencement of the TOBA II BTK clinical study. The Tack Endovascular System is uniquely tailored for use in arteries below the knee. These arteries are small in diameter, so the minimal metal burden associated with the Tack implant and the Tack implant’s ability to adapt to the diameter of the artery are both ideal for dissection repair in this part of the leg.”

About the Tack Endovascular System
The Tack Endovascular System is a new technology designed to repair dissections that frequently occur as a complication of balloon angioplasty. The system allows physicians to repair dissections while leaving a minimal amount of foreign material in the artery, reducing mechanical stress on the artery, and preserving future treatment options. When dissections are left unrepaired, they increase the probability of acute blockage or repeat narrowing of the artery.

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.

Bosiers M, Scheinert D, Hendriks JM, Wissgott C, Peeters P, Zeller T, Brodmann M, Staffa R; TOBA investigators. “Resultsfrom the Tack Optimized Balloon Angioplasty (TOBA)study demonstrate the benefits of minimal metal implantsfor dissection repair after angioplasty.” J Vasc Surg. 2016 Jul;64(1):109-16. doi: 10.1016/j.jvs.2016.02.043. Epub 2016 Apr 29. 2
Brodmann M, Wisgott C, Holden A, Staffa R, Vasudevan T, Zeller T. “TOBA BTK 12-Month Results: A New Method for Treating CLI with Post-PTA Dissections.” Presented at the Society for Cardiac Angiography and Interventions 2016.
Contacts
Intact Vascular, Inc.
Andrea Dunkle, adunkle@intactvascular.com, 1-484-253-1048

Tack Endovascular System® and Tack® are registered trademarks of Intact Vascular, Inc.
The 6 French Tack Endovascular System® is CE Mark Authorized under EC Directive 93/42/EEC. (4 French pending)
Not Available for sale or use in the United States.
Under U.S. Federal Law, the Tack Endovascular System is Limited to Investigational Use in the TOBA II study only.

TOBA One-Year Clinical Study Results Published in the Journal of Vascular Surgery

By | 2016 Press Releases, Press Releases

August 15, 2016 – WAYNE, Pa.–(BUSINESS WIRE)–Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today announced that the one-year results from its Tack Optimized Balloon Angioplasty (“TOBA”) clinical study were published in the July 2016 edition of the Journal of Vascular Surgery1.

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, which are located in the upper part of the leg. All participants underwent percutaneous balloon angioplasty (“PTA”) with any dissections (or tears) resulting from PTA repaired using the Tack Endovascular System. The Tack® implant is a new technology designed to repair dissections in the artery wall that frequently occur as a complication during PTA. The system allows physicians to repair these dissections while leaving a minimal amount of foreign material in the artery, which reduces mechanical stress on the artery; leaves the artery in its most natural state; and preserves future treatment options. If the dissections are left unrepaired, they increase the probability of acute artery occlusion or may continue narrowing the artery.

Some key conclusions from the TOBA study included:

98.5% participants achieved technical success
76.4% 12-month primary patency
89.5% freedom from target lesion revascularization (TLR)
82.8% participants had a Rutherford Classification grade ≤1 at 12 months, representing a significant improvement in function from baseline
Marc Bosiers, M.D. (A.Z. St. Blasius Hospital, Dendermonde, Belgium) was the Principal Investigator for the TOBA study. Dr. Bosiers stated, “These one-year results from the TOBA study demonstrate that the minimal metal approach associated with the Tack implant produces positive, lasting results in patients with severe peripheral artery disease. This is a high cost, resource intensive disease, so treatments with long-term effectiveness, such as combining angioplasty with the Tack implant, bring substantial benefits for patients and payers alike.”

Peter Schneider, M.D. (Chief of Vascular at the Kaiser Foundation Hospital in Honolulu) Intact Vascular’s Co-Founder and Chief Medical Officer, added, “This first, large-scale study investigating the safety and efficacy of the Tack Endovascular System is a key building block for the broad clinical development program we are pursuing at Intact Vascular. Plain PTA in this setting typically has a one-year patency rate of 30-55%. When we added the Tack device to the treatment, the one-year success was improved to 76.4%. Our next studies involve combining the Tack system with drug-coated balloon angioplasty, which is the focus of our TOBA II and III clinical trials.”

Based on these promising results, Intact Vascular has been enrolling participants in an expanded study, TOBA II (www.toba-ii.com) that is being conducted at more than 35 U.S. and European centers under an Investigational Device Exemption (IDE) approval. The Company plans to submit data from TOBA II in support of a pre-market approval application with the FDA. Recently, the Company commenced enrollment in TOBA III, a post-CE Mark study conducted in Europe to assess the combination of the Tack implant and drug-coated balloon angioplasty in the superficial femoral and popliteal arteries.

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.

Bosiers M, Scheinert D, Hendriks JM, Wissgott C, Peeters P, Zeller T, Brodmann M, Staffa R; TOBA investigators. “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 Jul;64(1):109-16. doi: 10.1016/j.jvs.2016.02.043. Epub 2016 Apr 29.
Contacts
Intact Vascular, Inc.
Andrea Dunkle, adunkle@intactvascular.com, 1-484-253-1048

Tack Endovascular System® and Tack® are registered trademarks of Intact Vascular, Inc.
The 6 French Tack Endovascular System® is CE Mark Authorized under EC Directive 93/42/EEC. (4 French pending)
Not Available for sale or use in the United States.
Under U.S. Federal Law, the Tack Endovascular System is Limited to Investigational Use in the TOBA II study only.

Tack Optimized Balloon Angioplasty III (TOBA III) Clinical Trial Commences Enrollment with First European Implant of the Tack Endovascular System™

By | 2016 Press Releases, Press Releases

June 2, 2016 – 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 commenced enrollment, with the first patient treated by Prof. Klaus Brechtel at the Franziskus-Hospital in Berlin, Germany.

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 Admiral drug-coated angioplasty balloon in the treatment of peripheral arterial disease (PAD) in the superficial femoral and popliteal arteries. 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 allows physicians to repair these dissections while leaving a minimal amount of foreign material in the artery, reducing mechanical stress on the artery, and preserving future treatment options.

Prof. Brechtel stated, “One of our key goals when using drug coated balloons to perform peripheral angioplasty is to minimize inflammation of the treated artery and leave little foreign material behind. The Tack system is designed to allow us to repair arterial damage after angioplasty while minimizing vessel irritation and leaving far less metal behind than we would with the traditional stenting approach.”

The TOBA III study will be conducted at multiple sites across Europe and will enroll 200 patients in total, including a subgroup of patients with long arterial lesions. Eligible patients will have PAD treated with balloon angioplasty using the Medtronic IN.PACT 2 Admiral Drug-Coated Balloon and have a dissection in the artery wall immediately following angioplasty.

Prof. Brechtel continued, “The TOBA III trial will provide us with valuable information about the combination of two very promising technologies designed to treat PAD. We are thrilled to be the first center to begin enrollment in this important study.”

Marc Penna, Vice President of Clinical Affairs at Intact Vascular, added, “The Tack Endovascular System is the ideal adjunct to drug-coated balloon angioplasty. It allows physicians to treat arterial damage in a highly targeted way and address their goals of reducing stress and irritation on the artery. We have a robust clinical development portfolio that is designed to demonstrate the power of this technology combination on the endovascular treatment of PAD.”

Intact Vascular is also sponsoring the TOBA II study, which is investigating the combination of the Tack Endovascular System with uncoated angioplasty balloons and the BARD Lutonix® Drug-Coated Balloon in patients with superficial femoral and popliteal artery disease. Future plans include conducting the TOBA II BTK clinical trial to assess the performance of the Tack Endovascular System following balloon angioplasty in patients with arterial disease below the knee.

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, adunkle@intactvascular.com, 1-484-253-1048
Tack Endovascular System™ and Tack™ are trademarks of Intact Vascular, Inc. The Tack Endovascular System™ is CE Mark Authorized under EC Directive 93/42/EEC. Not Available for Sale in the United States.
CAUTION: Investigational device. Limited by Federal (United States) law to investigational use.

Positive Twelve-Month Tack Optimized Balloon Angioplasty Below-the-Knee (TOBA-BTK) Results Presented at SCAI 2016

By | 2016 Press Releases, Press Releases

May 4, 2016 – WAYNE, Pa.–(BUSINESS WIRE)–Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today announced that positive twelve-month results from its Tack Optimized Balloon Angioplasty – Below-the-Knee (TOBA-BTK) clinical study were presented at the SCAI 2016 conference by Dr. Christian Wissgott, Assistant Director, at Westküstenklinikum Heide in Heide, Germany.

The TOBA-BTK study enrolled 35 subjects at 6 sites in Europe and New Zealand. All study subjects were suffering from critical limb ischemia, a form of peripheral arterial disease, in one or both legs. Of the subjects enrolled, 32 were treated with the 4 French Tack Endovascular System following standard balloon angioplasty in the tibial and peroneal arteries. 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 allows physicians to repair these dissections while leaving a minimal amount of foreign material in the artery, reducing mechanical stress on the artery, and preserving future treatment options.

Some of the key conclusions from the TOBA-BTK study included:

78.4% 12-month primary patency
89.2% 12-month primary assisted patency
93.5% freedom from target lesion revascularization (TLR)
84.5% amputation-free survival
87.1% freedom from major amputation
Dr. Wissgott stated, “Restoring blood flow to the legs in patients with critical limb ischemia is vitally important to their quality of life and survival. We have few treatments that have a demonstrated ability to keep the small arteries below the knee open over 12 months, so these TOBA-BTK results are truly encouraging. These data suggest that repairing arterial dissections following angioplasty below the knee, using the minimal metal design approach of the TackTM implant, can keep the treated arteries open and blood flowing.”

Patients in the study demonstrated a marked improvement, as measured by the Rutherford Classification System, a 7-stage scale ranging from no symptoms (class 0) to gangrene (class 6). The study data suggest that an increasing number of patients continue to improve, with 75% of patients experiencing a 4 or 5 step improvement in Rutherford Classification from baseline (p<0.0001) at 12 months. Dr. Wissgott continued, “The Tack Endovascular System holds much promise for improving the long term outcomes associated with balloon angioplasty below the knee. I look forward to building on these exciting results in the expanded TOBA II BTK clinical trial that is currently being planned.” Peter Schneider, M.D., Chief of Vascular Therapy at the Kaiser Foundation Hospital in Honolulu, and Intact Vascular’s Founder and Chief Medical Officer, added, “The existing treatments for arterial dissections below the knee involve leaving a great deal of metal behind, and in the small arteries of the lower leg that is plagued with problems. The Tack implant takes a very novel approach and allows the treating physician to target therapy only where it is needed to promote healing of the injured artery.” Based on these promising results, the company is pursuing an expanded study (TOBA II BTK) that will assess the performance of the Tack Endovascular System in a larger population and will include U.S. and international investigators. 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, adunkle@intactvascular.com, 1-484-253-1048 Tack Endovascular System™ and Tack™ are trademarks of Intact Vascular, Inc. The Tack Endovascular System™ is CE Mark Authorized under EC Directive 93/42/EEC. Not Available for Sale in the United States. CAUTION: Investigational device. Limited by Federal (United States) law to investigational use.

Positive Six-Month Tack Optimized Balloon Angioplasty Below-the-Knee (TOBA-BTK) Results Presented at LINC 2016

By | 2016 Press Releases, Press Releases

January 26, 2016 – WAYNE, Pa.–(BUSINESS WIRE)–Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today announced that positive six-month results from its Tack Optimized Balloon Angioplasty – Below-the-Knee (TOBA-BTK) clinical study were presented at the LINC 2016 conference by principal investigator, Dr. Marianne Brodmann, Head of the Clinical Division of Angiology, at Medical University of Graz in Austria.

The TOBA-BTK study enrolled 35 subjects at 6 sites in Europe. All study subjects were suffering from critical limb ischemia, a form of peripheral arterial disease, in one or both legs. Of the subjects enrolled, 32 were treated with the 4 French Tack Endovascular System following standard balloon angioplasty in the tibial and peroneal arteries. 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 allows physicians to repair these dissections while leaving a minimal amount of foreign material in the artery, reducing mechanical stress on the artery, and preserving future treatment options.
Some of the key conclusions from the TOBA-BTK study included:
• 87.1% 6-month primary patency
• 93.5% 6-month assisted primary patency
• 93.5% freedom from TLR
• 96.8% amputation-free survival
• 100% freedom from death
• 100% freedom from major amputation

Dr. Brodmann stated, “The clinical outcomes of the TOBA-BTK experience are very positive in a patient population that is challenging to treat with current therapies and consumes significant healthcare resources. This new approach to repairing arterial dissections below the knee demonstrates the benefit of minimizing vessel trauma and leaving minimal metal behind. The Tack supports the dissection and allows the vessel to heal, while preserving future treatment options for our patients.”

Patients in the study demonstrated a marked improvement, as measured by the Rutherford Classification System, a 7-stage scale ranging from no symptoms (class 0) to gangrene (class 6). The study data suggest that an increasing number of patients continue to improve, with a 70% reduction in patients with Rutherford class 5 disease at 6 months. This group of patients accounted for almost 90% of the patients studied. Most importantly, none of the patients have had a major amputation at 6 months.

Professor Brodmann said, “This new approach of low radial force and spot treatment of dissections may be a perfect partner for use with drug-coated balloons in the treatment of BTK disease. I look forward to presenting the 12-month TOBA-BTK data in the near future.”

Bruce J. Shook, Intact Vascular’s President & CEO, added, “These results represent exciting promise for patients suffering from critical limb ischemia. This population is severely underserved and growing. We are allocating significant resources at Intact Vascular toward development of the Tack implant technology for the treatment of critical limb ischemia, including a much expanded clinical development program.”

Based on these promising results, the company is pursuing an expanded study (TOBA II BTK) that will assess the performance of the Tack Endovascular System in a larger population and will include U.S. investigators.

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, adunkle@intactvascular.com, 1-484-253-1048
Tack Endovascular System™ and Tack™ are trademarks of Intact Vascular, Inc. The Tack Endovascular System™ is CE Mark Authorized under EC Directive 93/42/EEC. Not Available for Sale in the United States.
CAUTION: Investigational device. Limited by Federal (United States) law to investigational use.