June 16, 2020
Keystone Heart Acquires 510 Kardiac Devices, Inc.
June 16, 2020—Keystone Heart, Ltd. announced it has acquired 510 Kardiac Devices, Inc., a privately held medical device company that manufactures the Lim transseptal system.
Keystone Heart, a Venus Medtech company, is a structural heart medical device company headquartered in Israel with United States operations in Tampa, Florida. 510 Kardiac Devices is a development-stage company focused on technologies for which there is a simple, clear path to approval (ie, 510[k] or simpler) and for a growing, established market for which a reimbursement search is already established.
According to the announcement, the Lim transseptal system is for left-sided structural heart procedures requiring a transseptal approach. It is designed to make transseptal punctures more effective and efficient while minimizing complications. This system will play a key role in procedures including percutaneous treatment of mitral valve disease, percutaneous occlusion of the left atrial appendage, and electrophysiology procedures. The device is not cleared for use and is not approved for commercial distribution in the United States. It does not have CE Mark approval.
In the announcement, Keystone Heart's President & CEO Chris Richardson commented, “At Keystone Heart, we are dedicated to delivering innovative products that fulfill unmet needs—like our TriGuard, which is the only CE Mark cerebral embolic protection device designed to cover and protect all three cerebral vessels during transcatheter heart procedures. With the increase in left-sided structural heart procedures, interventional cardiologists are being asked to puncture and cross the interatrial septum using specific puncture locations on challenging anatomies. Adding the Lim transseptal system allows us to broaden our portfolio and fortify our long-term strategy of offering total package solutions for structural heart procedures.”