The next multi-billion-dollar blockbuster for treatment of heart disease will be the bioresorbable vascular scaffold (BVS), which also restores blood flow through a diseased artery, but then dissolves into the body.
"The long-term benefits are huge. Since the stent will leave the body after two years after doing its work of clearing blockages, the patient will not have to take blood-thinning medicines lifelong," says Dr. Samin K. Sharma, who heads the Clinical & Interventional Cardiology department at Mount Sinai Medical Center in New York.
Who will be the winners and losers?
Abbott (Abbott Park, IL) is the leader right now. The Absorb BVS is a small mesh tube made of polylactide (PLLA). It is coated with a medication to reduce inflammation and tissue growth to help prevent renarrowing of the artery. Absorb is authorized for sale in CE Mark countries and is available in Europe, the Middle East, parts of Latin America, and parts of Asia Pacific, including India, Hong Kong, Malaysia and New Zealand. The ABSORB III clinical trial will enroll approximately 2250 patients, the majority in the United States.
Reva Medical (San Diego, CA) has a competing plastics technology, but is less far along. It is now engaged in a CE Mark trial for devices made from desaminotyrosine polycarbonate, which has advantages and disadvantages compared to PLLA. Boston Scientific made a sizable investment in Reva, but let an option to acquire lapse, leaving it potentially vulnerable in the BVS space. Boston Scientific may still distribute the Reva stent.
Elixir (PLLA) and Biotronik (magnesium alloy) are also players in the market. Asian companies are trying to develop technology.
On the processing side, American Kuhne is introducing a micro extruder specially designed for challenging medical jobs, including making stents from PLLA, which is difficult to form because of its weak thermal properties.
On the materials side, the big players in medical-grade PLLA are Purac, which is building a U.S. plant for its very pure lactide products, and Evonik, which in 2011 bought the Resomer business of Boehringer Ingelheim Pharma GmbH & Co.
Other winners will be an emerging class of specialists such as TESco Associates (Tyngsborough, MA), which develops specialty bioresorbable compounds with materials suppliers and has proprietary injection molding processes.
The losers will be the huge suppliers of metallic stents that have not developed a position in bioresorbable stents. Even if they jump in now, Abbott has a big lead.
