Keystone Heart has acquired 510 Kardiac Devices, Inc., a privately-held medical device company and makers of the Lim Transseptal System.
The Lim Transseptal System was designed to meet the demands of left-sided structural heart procedures requiring a transseptal approach. 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. It is designed to provide physicians with an increased level of device control, functionality, and visibility, making transseptal punctures more effective and efficient while minimizing costly complications. The intuitive handle design allows steering in two unique planes, along with the ability to advance the dilator in a precise and controlled manner. The system incorporates fluoroscopic and echogenic markers on the distal end for increased visibility while delivering excellent torque transmission and kink resistance via a braided catheter construction design.
“At Keystone Heart, we are dedicated to delivering innovative products that fulfill unmet needs – like our TriGUARD 3™, which is the only CE Marked cerebral embolic protection device designed to cover and protect all three cerebral vessels during transcatheter heart procedures,” stated Chris Richardson, Keystone Heart President & CEO. “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.”
“We are excited to be joining an innovative company like Keystone Heart,” said Jaime Sarabia, 510 Kardiac Devices Inc. Co-founder and CEO. “Procedures requiring a transseptal approach will grow dramatically over the next several years, and the Lim Transseptal System will help to differentiate Keystone Heart as a leader within these new therapies. This partnership provides us the distinct opportunity to bring our pioneering technology into the US & Europe by partnering with a team that is known for excellent product development and go-to-market experience.”
The Lim Transseptal System is not cleared for use in the US, not approved for commercial distribution in the US, and not CE marked.
About Keystone Heart Ltd.
Keystone Heart, a Venus Medtech company, is a structural heart medical device company developing and manufacturing 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. We are committed to developing and delivering gold standard cardiac therapies that promote positive health economic outcomes. The company’s management team has extensive experience in the fields of interventional cardiology and medical devices. Keystone Heart holds and maintains a comprehensive IP portfolio and is ISO certified.
About 510 Kardiac Inc.
510 Kardiac Devices, Inc. is a development-stage company dedicated to providing novel cardiovascular devices through which cardiologists can perform procedures to targeted locations within the structures of the heart. Our intuitive platform provides physicians with an increased level of device control, functionality, and visibility. Our practical business strategy is to pursue technologies for which there is a simple and clear path to approval (510 (k) or simpler) in a growing established market for which reimbursement search is already established.
For additional information on Keystone Heart, visit www.keystoneheart.com