Cardiological Solutions, a Los Altos, Calif.-based emerging cardiovascular device firm, has initiated operations. The new company was born of a merger between Emboline Inc. and VasoStitch Inc., but financial details of the merger have not been disclosed. Former VasoStitch President/CEO David W. J. Smith now runs Cardiological Solutions.

The large-hole access and closure technologies of VasoStitch and the aortic embolic protection technologies of Emboline form the initial core of a family of accessory devices offered by Cardiological Solutions to address the clinical needs of emerging interventional cardiology procedures. Added to these is an approach to preventing contrast nephropathy (an abnormal increase of serum creatinine, a by-product of the breakdown of high-energy phosphates in muscles) during cardiovascular procedures. Cardiological Solutions’s technologies are derived from intellectual property invented by serial entrepreneur Amir Belson, M.D., founder of NeoGuide Systems Inc., Vascular Pathways Inc., Zipline Medical, Thermocure Inc. and Radguard Medical Inc.

“Recent developments in interventional cardiology have created compelling opportunities for new types of procedural accessory devices,” said Belson. “Specifically, the recent emergence of transcatheter aortic valve replacement (TAVR) therapies has created a critical need for non-surgical, large-hole (>12 Fr) access and closure technologies, aortic embolic protection devices for prevention of stroke and other ischemic complications, and prevention of contrast nephropathy. The combined potential of these markets where there exists now a strong clinical need is estimated at $2 to 3 billion annually, and this is the immediate focus of Cardiological Solutions.”

“Merging these companies will both create cost-efficiencies and enhance the value of the combined enterprise,” added Smith. “The broad portfolio of Cardiological Solutions represents the most comprehensive range of accessory products for the TAVR community. Our technologies address the three biggest clinical needs in TAVR, with technologies and a broad intellectual property portfolio.”

Cardiological Solutions currently is raising money to achieve CE mark for the initial Emboline and VasoStitch products, and proof-of-concept for its contrast nephropathy technology. First commercial sales are estimated in the ninth calendar quarter following close of funding, beginning with the European launch of the first VasoStitch product, followed by the European launch of the first Emboline device roughly six months later. There currently are no Cardiological Solutions products for sale in the United States.

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