News | August 26, 2013

Boston Scientific Completes Enrollment In SuperNOVA Trial

Trial evaluates Innova Self-Expanding Stent System

August 26, 2013 — Boston Scientific Corp. has completed enrollment in the SuperNOVA trial – a global, single arm, prospective, multicenter clinical trial evaluating the long-term (12-month) safety and effectiveness of the Innova Self-Expanding Stent System (Innova Stent System). This stent system is designed for treating patients with a narrowing or blockage of the arteries above the knee, often associated with peripheral artery disease (PAD).

The study enrolled 299 patients at 51 sites in the United States, Canada, Japan and Europe and is expected to support regulatory submissions in the United States, Canada and Japan.

"Treating vascular lesions in the superficial femoral artery (SFA) and proximal popliteal arteries (PPA) is particularly challenging due to a variety of anatomical factors, including vessel length and tortuosity," said Richard Powell, M.D., section chief, department of vascular surgery, Dartmouth Hitchcock Medical Center, Lebanon, N.H., professor of surgery and radiology at Geisel School of Medicine, and global principal investigator of the SuperNOVA trial. "From my experience in the clinical trial, the Innova Stent System offered the design characteristics required for acute and long term success in these challenging vessels, including radial strength, flexibility, fracture resistance and long stent lengths."

The Innova Stent System consists of a nitinol self-expanding, bare-metal stent loaded on an advanced low-profile delivery system. The stent architecture features a uniform, open-cell structure along the stent body designed for enhanced flexibility, radial strength and fracture resistance and a closed-cell design at each stent end for uniform deployment. The delivery system of the Innova Stent System features a tri-axial delivery catheter with an outer stabilizer sheath engineered to enhance deployment accuracy. The Innova Stent is 6 French compatible and available outside the United States in diameters from 5-8 mm and lengths of 20-200 mm.

More than 27 million people worldwide suffer from PAD, a buildup of plaque that narrows and blocks the arteries, reducing blood flow to the limbs. PAD most commonly occurs in the pelvis and legs, sometimes causing symptoms such as cramping, numbness and pain in the calves or thighs while walking. Left untreated, PAD of the lower extremities can lead to painful wounds on the feet and toes, infections or amputation.

The Innova Stent System received CE mark approval in May 2012. In the United States, the device is investigational and not available for sale.

For more information: www.bostonscientific.com

Related Content

FDA Clears Corindus CorPath GRX for Peripheral Vascular Interventions
Technology | Peripheral Artery Disease (PAD) | February 20, 2018
Corindus Vascular Robotics Inc. announced today that it received 510(k) clearance from the U.S. Food and Drug...
News | Peripheral Artery Disease (PAD) | December 29, 2017
December 29, 2017 — iVascular announced the release of the new Oceanus 14 Pro percutaneous transluminal angioplasty (
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...
Philips Showcases Integrated Vascular Solutions at VIVA 2017
News | Peripheral Artery Disease (PAD) | September 13, 2017
Philips announced its presence at the Vascular Interventional Advances (VIVA 17) Annual Conference in Las Vegas from...
PQ Bypass Reports Positive Results for Detour System in Patients With Long Femoropopliteal Blockages
News | Peripheral Artery Disease (PAD) | September 13, 2017
A subset analysis of the DETOUR I clinical trial showed promising safety and effectiveness results of PQ Bypass’ Detour...
Ra Medical Systems Granted Broad Patent for DABRA Catheter
News | Peripheral Artery Disease (PAD) | August 09, 2017
August 9, 2017 — Ra Medical Systems announced that the United States Patent and Trademark Office (USPTO) has granted
The LimFlow Percutaneous Deep Vein Arterialization System (pDVA) converts veins into arteries to restore blood flow in critical limb ischemia (CLI).

The LimFlow Percutaneous Deep Vein Arterialization System (pDVA) converts veins into arteries to restore blood flow in critical limb ischemia (CLI). This image shows how the covered stents used with the system connect to create a new arterial pathway.

News | Peripheral Artery Disease (PAD) | August 02, 2017
Aug.
Sponsored Content | Videos | Peripheral Artery Disease (PAD) | July 25, 2017
This video case study, provided by Gore Medical, is titled "Tackling Complex Cases in Dialysis Access," by John Ross,
First Patient Treated in U.S. Feasibility Study of LimFlow Critical Limb Ischemia Device
News | Peripheral Artery Disease (PAD) | July 17, 2017
LimFlow SA announced enrollment of the first patient in the U.S. feasibility study of the LimFlow Percutaneous Deep...
Overlay Init