News | Peripheral Artery Disease (PAD) | October 01, 2015

FDA OKs Intact Vascular Trial for Tack Optimized Balloon Angioplasty II Study

TOBA II Study designed to demonstrate enhanced dissection repair following balloon angioplasty

Intact Vascular, TOBA II study, Tack Endovascular System

Image courtesy of Intact Vascular
 

October 1, 2015 — Intact Vascular Inc. announced the U.S. Food and Drug Administration has granted conditional approval for a U.S. and European investigational device exemption (IDE) clinical trial of the Tack Endovascular System. The device will be investigated for use as a dissection repair therapy in patients with peripheral arterial disease (PAD) 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 in Yuma, Arizona.

William A. Gray, M.D., 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 PAD 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.

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 percent of angioplasty procedures have dissections. Earlier this year, promising 12-month results from the company’s European TOBA study were presented 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.

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. 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.”

For more information: www.intactvascular.com

Related Content

Biotronik Studies Demonstrate Efficacy of Minimizing Metal Burden in SFA Therapy
News | Stents Bare Metal| September 22, 2017
Physicians demonstrated that reducing metal burden in superficial femoral artery (SFA) therapy could effectively reduce...
Edwards Inspiris Resilia Valve Receives FDA Approval
News | Heart Valve Technology| September 21, 2017
Edwards Lifesciences Corp. recently received U.S. Food and Drug Administration (FDA) approval for its Inspiris Resilia...
MyoKardia Presents Additional Positive Data From Phase 2 PIONEER-HCM Study at HFSA 2017
News | Heart Failure| September 21, 2017
MyoKardia Inc. announced that additional positive data from the first patient cohort of its Phase 2 PIONEER-HCM study...
Tryton Side Branch Stent Recognized With Premier Technology Breakthrough Award
News | Stents Bifurcation| September 21, 2017
September 21, 2017 — Cardinal Health and Tryton Medical Inc.
Lesion Preparation Via Atherectomy Enhances Paclitaxel Distribution in Calcified Peripheral Arteries
News | Peripheral Artery Disease (PAD)| September 20, 2017
September 20, 2017 — Not-for-profit preclinical research institute CBSET announced that its scientists have published
DISRUPT BTK Study Shows Positive Results With Lithoplasty in Calcified Lesions Below the Knee
News | Peripheral Artery Disease (PAD)| September 20, 2017
Shockwave Medical reported positive results from the DISRUPT BTK Study, which were presented at the annual...
Corindus Announces First Patient Enrolled in PRECISION GRX Registry
News | Robotic Systems| September 18, 2017
September 18, 2017 — Corindus Vascular Robotics Inc.
Two-Year ILLUMENATE Trial Data Demonstrate Efficacy of Stellarex Drug-Coated Balloon
News | Drug-Eluting Balloons| September 18, 2017
Philips announced the two-year results from the ILLUMENATE European randomized clinical trial (EU RCT) demonstrating...
Sentinel Cerebral Protection System Significantly Reduces Stroke and Mortality in TAVR
News | Embolic Protection Devices| September 18, 2017
September 18, 2017 – Claret Medical announced publication of a new study in the...
Fysicon Receives FDA Approval for QMAPP Hemodynamic Monitoring System
Technology | Hemodynamic Monitoring Systems| September 18, 2017
Fysicon announced that it has been granted 510(k) clearance by the U.S. Food and Drug Administration (FDA) for its...
Overlay Init