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Durability of Drug-Coated Balloons

People suffering from cardiovascular disease may have another option for treatment: drug-coated balloons. Merging established angioplasty balloon catheter technology with active drug coatings, this evolving medical technology will be covered in a proposed new ASTM standard, 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 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.

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:

  • WK8279, Terminology Relating to Vascular Stents;
  • WK17454, Guide for In-Vivo Arterial Deformations and Cycles;
  • WK29690, Guide for Fatigue to Fracture in an Effective Way; and
  • WK34602, Guide for Radial Loading of Balloon Expandable and Self-Expanding Vascular Stents.

CONTACT Technical Information: Gary Binyamin, TriReme Medical LLC • Kensington, Calif. • Phone: 650-823-0710 | ASTM Staff: Pat Picariello • Phone: 610-832-9720 | Upcoming Meeting: Nov. 10-14 • November Committee Week • New Orleans, La.

This article appears in the issue of Standardization News.