Abbott Laboratories Launches Innovative Coronary Stent in the United States

06-Jul-2001

Abbott Laboratories announced today the availability of the BiodivYsio™ Added Support (AS) coronary stent in the United States. The stent is coated with a proprietary phosphorylcholine (PC) coating technology. PC Technology™ is a synthetic polymer copy of the outside surface of a red blood cell, which mimics the structure of the natural cell membrane. The PC coating confers properties of hemocompatibility and is designed to reduce the body's response to implanted devices - minimizing thrombus, or clot formation, and inflammation. Abbott will market the BiodivYsio AS stent in the United States under an exclusive, multi-year agreement it announced in November 1999 with Biocompatibles International plc.

"Abbott's portfolio of differentiated vascular devices will take a major step forward with the introduction of the BiodivYsio AS stent," said Christopher B. Begley, senior vice president, hospital products, Abbott Laboratories. "The launch of this innovative, technologically advanced product will offer physicians a new alternative for the effective treatment of coronary artery disease."

In DISTINCT, a large randomized trial utilizing PC Technology, there were no cases of sub-acute thrombosis. "The impressive clinical data on the BiodivYsio stent were generated against the market leader," said Jeffrey Moses, M.D., of Lenox Hill Hospital, N.Y., principal investigator in the DISTINCT clinical trial. "With its unique coating, this stent provides an exciting new offering in the U.S. and broadens our treatment options."

The BiodivYsio AS stent is indicated for the treatment of de novo native coronary artery lesions of less than 25 mm length with a reference vessel diameter ranging from 3.0 mm to 4.0 mm. The stent is available in 11 mm and 15 mm lengths.

Abbott will market the BiodivYsio AS stent in the United States through its Perclose subsidiary's leading interventional cardiology sales force. The AS stents are one of three parts of the BiodivYsio coronary stent family, which also include the Small Vessel (SV) and Open Cell (OC) stents. The Pre-Market Approval (PMA) supplement for the SV stent was submitted in June, and the U.S. Food and Drug Administration (FDA) submission for the OC stent is expected to occur in the second half of 2001.

"We are delighted to receive this approval and to give Abbott the opportunity to put the first in a series of BiodivYsio stents into its unique offering of interventional cardiology products in the United States," said Stephen Terry, managing director of Biocompatibles' Cardiovascular division.

In a related effort, Abbott has entered into a non-exclusive, strategic licensing agreement with Cordis Corporation, a wholly owned unit of Johnson & Johnson, under which Abbott shall have the right to market and sell, among other products, the BiodivYsio stent in the United States. Financial terms of the agreement were not disclosed.

Abbott's expanding vascular medicine franchise includes both medical devices and therapeutics and focuses on high growth market segments including vessel closure, embolic capture, coated stents and occlusion catheter technologies. For each of these vascular markets, a strong product pipeline is being assembled to build and develop a growth business in the multibillion-dollar acute care vascular market. The combination of unique devices and drugs plays a critical role in serving this market, and together will provide a differentiated position for Abbott.

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