BSX products launched in Europe
Boston Scientific has launched European sales of products designed to treat peripheral artery and aortic valve diseases.
The Marlborough-based medical device maker said both its Ranger Drug-Coated Balloon and its 25- millimeter Lotus valve system have achieved CE Mark approval, a manufacturing conformity requirement in Europe.
The Ranger Drug-Coated Balloon is aimed at improving the consistency and predictability of drug delivery to patients suffering from peripheral artery disease, a circulatory disorder resulting from the build-up of plaque in the legs or other arteries. The device can deliver a drug to diseased vascular tissue without leaving any permanent implant behind.
“I am excited by the technology in the Ranger Drug-Coated Balloon, which has the potential to reduce drug loss significantly while optimizing both deliverability and the absorption of the drug in the targeted tissue,” said Dr. Dierk Scheinert at Park Krankenhaus in Germany.
For the Lotus Transcatheter Aortic Value Implantation System, a six-month study in select hospitals across Europe and Australia found that just 1.1 percent of patients treated with the 25-millimeter valve experienced serious problems, none of which were serious. This product will complement 23- and 27- millimeter valve systems launched in late 2013.
“Having the 25- millimeter size allows us to be more precise in selecting the appropriate valve, which we anticipate will further improve outcomes for our patients,” said Dr. Nicolas Van Mieghem at Erasmus Medical Center in The Netherlands.
The product is intended to address aortic valve stenosis, the thickening and stiffening of the aortic valve which can result in the reduction of blood flow to the heart. The average survival rate after two years is 50 percent, and after five years, just 20 percent.
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