News | January 30, 2007

Longer Balloon Enables Expanded Peripheral Interventions

Jan. 31, 2007 — Boston Scientific Corp. days it has received FDA 510(k) clearance to expand its PolarCath Peripheral Dilatation System offering to include a 100mm balloon. The system is used to restore blood flow and reduce the risk of amputation in patients with critical limb ischemia (severe blockages in the arteries below the knee), or femoropopliteal blockage, a result of peripheral artery disease.

The new, 100mm balloon is available in both 0.014-inch and 0.035-inch diameters. The PolarCath System also offers balloon lengths of 20, 40, 60 and 80mm.

The novel form of balloon angioplasty that utilizes the PolarCath System — called CryoPlasty — is a less invasive was to prevent amputation in patients with severe peripheral artery disease, according to John Pedersen, president of Boston Scientific's Peripheral Interventions business.

Cryoplasty cools the inside of occluded arteries in the legs while opening the blockages; nitrous oxide is used to fill an angioplasty balloon within a blocked artery, cooling the balloon's surface to -10 degrees C. Boston Scientific reports that as the balloon is inflated, the cold surface of the balloon cools the vascular lesion, which may help prevent re-blockage of the artery. Efficacy of the therapy using the PolarCath Peripheral Dilatation System was demonstrated in the Below-The-Knee (BTK) CHILL trial.

The procedures are usually performed within a few hours and can provide significant pain relief. Pederson says that the availability of the longer balloon length will enable interventionalists to address a wider range of the debilitating blockages more efficiently, including longer lesions in the subfemoral arteries.

For more information visit www.bostonscientific.com..

Related Content

News | Drug-Eluting Balloons| August 15, 2017
Surmodics Inc. announced receipt of an investigational device exemption (IDE) from the U.S. Food and Drug...
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.
Spectranetics Announces FDA Approval of Stellarex Drug-Coated Balloon
Technology | Drug-Eluting Balloons| July 26, 2017
The Spectranetics Corp. announced receipt of U.S. Food and Drug Administration (FDA) pre-market approval (PMA) of the...
First European Patient Enrolled in Intact Vascular's TOBA II BTK Trial
News | Stents Peripheral| July 26, 2017
Intact Vascular Inc. recently announced that its Tack Optimized Balloon Angioplasty II Below the Knee (TOBA II BTK)...
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...
FDA Approves Six-Month Primary Endpoint for Tack Endovascular System in Below the Knee Disease
News | Stents Peripheral| July 14, 2017
Intact Vascular Inc. announced the U.S. Food and Drug Administration (FDA) approved an Investigational Device Exemption...
Philips Announces Relaunch of Pioneer Plus IVUS-Guided Catheter
News | Chronic Total Occlusion (CTO)| June 28, 2017
June 28, 2017 — Royal Philips recently announced the relaunch of its Pioneer Plus...
Shockwave Medical Announces U.S. Commercial Availability of Lithoplasty System
News | Peripheral Artery Disease (PAD)| June 26, 2017
Shockwave Medical recently announced two milestones for its Lithoplasty System for the treatment of calcified plaque in...
Overlay Init