“DEB therapy in combination with bare metal coronary stents offers a potential solution for reducing late lumen loss without the need for long term dual-anti-platelet medication, improving patient comfort and reducing risks for bleeding and stent thrombosis.”
CoCr stent on a Drug Eluting Balloon will become the standard choice for coronary vessels that require a stent treatment, says Blue Medical.
In short
Last week we posted an article about B Braun Melsungen’s evidence that Drug-Eluting Balloons(DEB), specifically its own “SeQuent® Please” device, produce better outcomes than uncoated derivatives when treating restenosed bare metal stents. Now Dutch Cardiovascular device company Blue Medical is announcing the global product launch of its own CE-approved Protégé DEB as well as its highly innovative combination of CoCr stent with its Pioneer DEB which it claims obviates the need for a drug-eluting stent and may have advantages over it.
Background
Founded in 1998 and located in the Dutch Brainport area, Blue Medical’s raison d’etre lies in developing innovative solutions in the treatment of cardiovascular and peripheral diseases. The company develops and manufactures stents and balloon angioplasty products, which are marketed on a global basis.
The company’s press release tells us that its novel DEB therapy delivers a controlled dose of Paclitaxel to the coronary artery during balloon angioplasty, as with the Braun product we covered last week. The combined device with a CoCr coronary stent delivers drugs during stent placement as a onetime shot only, instead of continuous drug delivery known from drug eluting stents. This is claimed to reduce the period in which anti-platelet medication could be required significantly.
Low MACE rates and low Late Lumen Loss indicating the efficacy and safety of the Protégé and Pioneer DEB Products are confirmed by the clinical data of Blue Medical’s Human Trial, PIONEER.
Clinician comments
“Increased late stent thrombosis risk and the long term dual anti-platelet medication which are associated with the majority of current drug eluting stents is a concern in treating our patients today,” said Primary Investigator of the PIONEER Study Peter Smits, M.D., head of Intervention Cardiology at the Maasstad Hospital, Rotterdam, The Netherlands. “DEB therapy in combination with bare metal coronary stents offers a potential solution for reducing late lumen loss without the need for long term dual-anti-platelet medication, improving patient comfort and reducing risks for bleeding and stent thrombosis.”
Company comments
“Our extensive research effort combined with human evaluation ensures a highly reliable science based and effective DEB technology.” said Ronald Horvers, CEO of Blue Medical, “The critical and extensive review of the Dutch Medicine Evaluation Board and notified body BSI enables us to provide an attractive alternative for treating coronary disease.”
SOURCE Blue Medical, PR Newswire
published: March 21, 2012 in: Approval/Clearance, Cardio, Clinical Studies/Trials, Companies, Launches / Withdrawals, Products, Regulatory