Keystone Heart to Distribute InterValve Medical’s Balloon Aortic Valvuloplasty Portfolio

March 25, 2021—Keystone Heart, Ltd. announced an exclusive distribution agreement with InterValve Medical Inc. to sell and market InterValve’s portfolio of balloon aortic valvuloplasty products in the United States. InterValve Medical, a Venus Medtech company, focuses on aortic valvuloplasty balloon catheters that dilate stenotic valve leaflets and the surrounding native tissue to increase aortic valve area and systemic blood flow.

InterValve’s V8 and TAV8 balloon catheters are FDA-cleared aortic valvuloplasty balloon catheters designed with an eight-shaped design. This shape is more in line with the anatomic structure of the aortic valve versus traditional long cylindrical aortic valvuloplasty balloons. Both balloon catheters are indicated for standalone valvuloplasty procedures and before and after transcatheter self-expanding heart valve replacement procedures.

Under the agreement, Keystone Heart began selling the V8 and TAV8 aortic valvuloplasty balloon catheters in the United States effective March 25, 2021.

Keystone Heart, also a Venus Medtech company, is headquartered in Israel with United States operations in Tampa, Florida.

Steve Sandweg, Keystone Heart’s General Manager, commented in the announcement, “The V8 and TAV8 are designed to offer physicians enhanced clinical utility to meet the needs of both pre- and postaortic dilatation. The V8 and TAV8 balloon catheters maintain their anatomic shape throughout inflation to reduce the likelihood of annular rupture while enhancing leaflet hyperextension in a timely fashion. Adding these devices to the Keystone Heart sales and marketing portfolio further solidifies our mission to provide best-in-class technology to meet the clinical needs of physicians and patients in the structural heart space.”