Healthcare Industry News:  ultrasound 

Devices Interventional FDA

 News Release - September 30, 2015

Intact Vascular Announces Conditional FDA Approval for Tack Optimized Balloon Angioplasty II (TOBA II) Study and Enrollment of First Patients

The TOBA II Study Is Designed to Demonstrate Enhanced Dissection Repair with the Tack Endovascular System™ Following Balloon Angioplasty

WAYNE, Pa.--(Healthcare Sales & Marketing Network)--Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today announced the U.S. Food and Drug Administration has granted conditional approval for a U.S. and European IDE clinical trial to investigate use of the Tack Endovascular System as a dissection repair therapy in patients with peripheral arterial disease (P.A.D.) undergoing percutaneous angioplasty. The Tack Optimized Balloon Angioplasty II (TOBA II) trial has begun with the first patients being treated at Yuma Regional Medical Center (Yuma, Arizona).

William A. Gray, MD, Director of Endovascular Services, at Columbia University Hospital, is providing study leadership as the national Principal Investigator.

The TOBA II study is designed to enroll 210 subjects at 30-40 sites in the United States and Europe. All study subjects need to be suffering from advanced peripheral artery disease in one or both legs. They will be treated with the Tack Endovascular System following standard balloon angioplasty or drug-coated balloon angioplasty in the superficial femoral and proximal popliteal arteries when a dissection (a tear in the artery wall) occurs (see www.TOBA-II.com for details).

The Tack Endovascular System is a new technology designed to repair dissections that frequently occur as a complication of balloon angioplasty. Published literature reports up to 88%1 of angioplasty procedures have dissections. Earlier this year, promising 12-month results from the Company’s European TOBA study were presented2 at a major vascular conference in Germany and demonstrated the potential of the Tack implant for improving arterial healing following angioplasty. Most importantly, 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.

Dr. Gray stated, “The earlier TOBA experience demonstrates that the long term results from angioplasty can be substantially improved if we repair arterial dissections using this new approach to minimize vessel trauma while leaving as little metal behind as possible. The Tack implant supports the dissection and allows the vessel to heal, while preserving future treatment options for patients. I am very excited that the TOBA II trial will allow us to study this technology in combination with both standard and drug-coated angioplasty balloons – a first of its kind study design. No other vascular implants have been methodically studied following vessel treatment with a drug-coated balloon.”

The first patients in the TOBA II trial were enrolled by Joseph Cardenas, M.D. at Yuma Regional Medical Center. Dr. Cardenas said, “This new approach of spot treating dissections supports our desire to leave as little metal behind as possible. The Tack implant is also uniquely designed to adapt to the diameter of the vessel in which it is implanted, unlike stents, which have to be specifically sized to the vessel. This makes the procedure fast, flexible and user-friendly for the hospital staff and the operator to efficiently treat our patients.”

Bruce Shook, President and CEO at Intact Vascular, stated, “We are thrilled by the enthusiasm and responsiveness of our clinical investigators, particularly Dr. Cardenas and his team at Yuma. The rapid commencement of this trial highlights the clinical need for a better method to repair arterial dissections and the keen interest clinicians have shown in a minimal metal solution to this growing problem.”

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.

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.

Sources:

1 van der Lugt, Gussenhoven EJ, Mali WPTM, Reekers JA, Seelen JL, Tielbeek AV, Pieterman H. Effect of Balloon Angioplasty in Femoropopliteal Arteries Assessed by Intravascular ultrasound. Eur J Endovasc Surg. 1997; 13:549-556.

2 Bosiers M. Tack Optimized Balloon Angioplasty: TOBA Trial 12 Month Results. Presented at: The Leipzig Interventional Course; 2015 Jan 27–30; Leipzig, Germany.


Source: Intact Vascular

Issuer of this News Release is solely responsible for its content.
Please address inquiries directly to the issuing company.



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