Cordis Returns to Drug-eluting Stent Market

May 16, 2016 — Cardinal Health announced it has entered into a distribution agreement with Biosensors that enables Cordis, Cardinal Health’s interventional vascular business, to sell Biosensors’ coronary stent portfolio. Cordis will sell Biosensors’ coronary stents in select countries in Europe, the Middle East, Africa, Australia and New Zealand. This marks Cordis’ return to the drug-eluting stent (DES) market and the beginning of a long-term partnership between Cardinal Health and Biosensors to further leverage their respective distribution capabilities in select regions. 

Cordis will now offer an expanded portfolio of products in select countries to further support the treatment of patients undergoing percutaneous coronary intervention (PCI), from access to intervention and closure. PCI is a nonsurgical procedure that often uses a catheter to place a stent to open blocked coronary arteries caused by coronary artery disease. Coronary artery disease is the most common type of heart disease and is expected to continue to be the leading cause of death globally for the next 20 years. 

“We are very excited about this DES agreement with Biosensors, because it represents our strong commitment to expand our product portfolio to support the demands in cardiovascular care today,” said David Wilson, president of Cordis, a Cardinal Health company. “While Cordis is known for developing product innovations, partnerships like this provide an opportunity to rapidly expand our unmatched portfolio and deliver increased value to customers and the patients they serve.” 

In the next few months, Cordis will begin offering Biosensors’ coronary stent portfolio, which includes the BioFreedom polymer-free drug-coated stent; the BioMatrix NeoFlex DES; BioMatrix Alpha, a cobalt chromium DES with an abluminal bio-absorbable coating; and the Chroma cobalt chromium bare metal stent (BMS), in select European countries, Australia and New Zealand. Over time, Cordis will begin to sell these products under the Lumeno private label in select countries, and both companies will continue to leverage their respective distribution capabilities in additional European countries, the Middle East, Africa and other parts of the world. 

Biosensors’ DES with a bio-absorbable coating and the Biolimus A9 drug are supported by multiple large-scale studies, including data from LEADERS, a prospective, randomized, multi-center clinical trial that demonstrated that the safety and efficacy of Biosensors’ BioMatrix Flex stent is comparable to that of a durable polymer DES in a population of 1,707 patients across 10 European centers. Additionally, data published in the New England Journal of Medicine from LEADERS FREE — the first prospective, double-blind, randomized clinical trial exclusively focusing on patients at high-bleeding risk receiving only one month of dual anti-platelet therapy (DAPT) — demonstrated superiority with respect to the primary safety and efficacy endpoints for BioFreedom as compared to a BMS in patients undergoing PCI. The trial assessed the shortest course of DAPT ever used with an active stent. LEADERS FREE included 2,466 patients across 68 sites in 20 countries in Europe, Asia, Australia and Canada, with a follow-up phase of two years.

Biosensors’ coronary stents have not been approved by the U.S. Food and Drug Administration and are not commercially available in the United States.

For more information: www.cordis.com