Keystone Heart Ltd. and InterValve Medical Inc. enter distribution agreement for balloon aortic valvuloplasty portfolio

TAMPA, Fla.March 25, 2021 /PRNewswire/ — Keystone Heart, Ltd., a medical device innovator driven to redefine the standard of structural heart care, today announced an exclusive distribution agreement with InterValve Medical Inc. to sell and market their portfolio of balloon aortic valvuloplasty products, in the United States.


InterValve Medical, a Venus Medtech company, focuses on offering pioneering aortic valvuloplasty balloon catheters that dilate stenotic valve leaflets and the surrounding native tissue to increase aortic valve area and systemic blood flow. The company’s trademark products, V8 and TAV8 balloon catheters, are the only FDA-cleared aortic valvuloplasty balloon catheters designed with a unique 8-shaped design, which is more in line with the anatomical structure of the aortic valve versus traditional long cylindrical aortic valvuloplasty balloons. Both balloon catheters are indicated for stand-alone valvuloplasty procedures and before and after transcatheter self-expanding heart valve replacement procedures.


Keystone Heart Ltd. General Manager Steve Sandweg sees the distribution agreement as a unique opportunity to build upon Keystone Heart’s structural heart offering. “The V8 and TAV8 are designed to offer physicians enhanced clinical utility to meet the needs of both pre and post aortic dilatation. The V8 and TAV8 balloon catheters maintain their anatomical 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.”


Under the agreement, Keystone Heart Ltd. will begin selling the V8 and TAV8 aortic valvuloplasty balloon catheters in the US market, effective March 25, 2021.


About Keystone Heart Ltd.

Keystone Heart, a Venus Medtech company, is a structural heart medical device company that develops and manufactures total package solutions for structural heart procedures. Headquartered in Israel, with US operations in Tampa, FL, Keystone Heart is dedicated to advancing patient care through innovative technology and clinical research. Keystone Heart is committed to developing and delivering gold standard cardiac therapies that promote positive healthcare economic outcomes. The company’s management team has extensive experience in interventional cardiology and medical devices. Keystone Heart holds and maintains a comprehensive IP portfolio and is ISO certified.


For additional information on Keystone Heart, visit


About InterValve Medical Inc.


InterValve, a Venus Medtech company, manufactures and distributes next-generation aortic valvuloplasty balloons to treat calcific aortic stenosis. The company was founded in 2008 by a highly experienced group of cardiologists and industry executives to develop new tools for the percutaneous and transapical aortic valve replacement procedure.


For additional information on Intervalve Medical, visit


Media contact:
Jennifer Anderson 
Phone: 720-471-4625


SOURCE Keystone Heart Ltd.

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