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ASTM Standard covers drug-coated cardiovascular balloons.
Press Release Summary:
Dec 09, 2014 - Proposed standard ASTM WK46148, Guide for Acute Durability of Drug-Coated Balloons, will cover evolving medical technology that merges established angioplasty balloon catheter technology with active drug coatings. Purpose of standard will be to provide consensus on suggested test methods for the acute characterization of drug-coated balloons. Primary users of ASTM WK46148 will be device developers, third-party testing facilities, academic groups, and regulatory agencies.
Original Press Release
Drug-Coated Balloons for Cardiovascular Treatment to Be Covered in Proposed ASTM Standard
Press release date: Aug 13, 2014
Merging established angioplasty balloon catheter technology with active drug coatings, this evolving medical technology will be covered in a proposed new ASTM standard, ASTM WK46148, Guide for Acute Durability of Drug-Coated Balloons.
“Drug-coated angioplasty balloon catheters are intended to open blockages in stenotic arteries of the body while minimizing restenosic response to treatment,” says ASTM member Gary Binyamin, Ph.D., director of science and technology, TriReme Medical LLC. Binyamin says that while drug-coated balloons are not yet approved for use in the United States at this time, several companies are pursuing approval for their versions of these products.
Primary users of ASTM WK46148 will be device developers, third-party testing facilities, academic groups and regulatory agencies. The purpose of the standard will be to provide consensus on suggested test methods for the acute characterization of drug-coated balloons.
ASTM WK46148 is being developed by Subcommittee F04.30 on Cardiovascular Standards, part of ASTM International Committee F04 on Medical and Surgical Materials and Devices. All interested parties are welcome to participate in the development of WK46148 and other F04.30 proposed standards, including the following:
• ASTM WK8279, Terminology Relating to Vascular Stents;
• ASTM WK17454, Guide for InVivo Arterial Deformations and Cycles;
• ASTM WK29690, Guide for Fatigue to Fracture in an Effective Way; and
• ASTM WK34602, Guide for Radial Loading of Balloon Expandable and Self-Expanding Vascular Stents.
ASTM International welcomes participation in the development of its standards. For more information on becoming an ASTM member, visit www.astm.org/JOIN. For more news in this sector, visit www.astm.org/snmedical or follow us on Twitter @ASTMMedical.
ASTM Committee F04 Next Meeting: Nov. 1014, 2014, November Committee Week, New Orleans, La.
TriReme Medical LLC
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