Medtronic announced today that it received CE mark for several expanded indications for its Prevail balloon catheter. The expanded indications for the paclitaxel-coated percutaneous transluminal coronary angioplasty (PTCA) balloon catheter (or drug-coated balloon/DCB) cover the treatment of coronary artery disease (CAD). According to the medtech … [Read more...] about Medtronic earns expanded CE mark for Prevail paclitaxel-coated balloon
Coatings
Cook Medical warns of issue with angiographic catheter
Cook Medical issued an urgent field safety notice in Europe to warn of an issue with its Beacon Tip 5.0 Fr angiographic catheter. The company identified an issue in which affected device lots may experience tip separation. This prompted Cook to request that customers remove devices from use, quarantining them and returning them to the … [Read more...] about Cook Medical warns of issue with angiographic catheter
FTC challenges private equity firm’s acquisition of Surmodics
The U.S. Federal Trade Commission (FTC) has sued to block the planned acquisition of medical device company Surmodics by GTCR. According to a news release, GTCR also owns a majority stake in Biocoat. The FTC says Biocoat is the second-largest provider of outsourced hydrophilic medical device coatings, behind only Surmodics. As a result, the FTC … [Read more...] about FTC challenges private equity firm’s acquisition of Surmodics
FDA approves IDE for Medtronic Prevail drug-coated balloon
Medtronic (NYSE: MDT) announced today that it received FDA investigational device exemption (IDE) for its Prevail drug-coated balloon (DCB). The medtech giant can now begin a pivotal clinical trial for the coronary paclitaxel DCB for in-stent restenosis (ISR) and de novo small vessel disease. It plans to use data from its Prevail Global Clinical … [Read more...] about FDA approves IDE for Medtronic Prevail drug-coated balloon
Cordis reports positive 2-year data for drug-eluting balloon
Cordis today announced positive 24-month results from a study evaluating its Selution SLR drug-eluting balloon (DEB). Selution SLR offers endovascular therapy for de novo and non-stented restenotic lesions in the superficial femoral artery (SFA) and the popliteal artery (PA). Cordis acquired the DEB technology from MedAlliance for $1.135 billion … [Read more...] about Cordis reports positive 2-year data for drug-eluting balloon
This medtech developer is throwing everything at clots
Retriever Medical is developing a thrombectomy system with a four-front approach for treating blood clots. The Las Vegas-based startup calls its technology VORS AMD, for vascular occlusion removal system with aspiration, mechanical and drug delivery. The approach combines nitinol baskets for mechanical thrombectomy with aspiration, clot-busting … [Read more...] about This medtech developer is throwing everything at clots
Zeus names first chief technology officer
Zeus today announced it named Suresh Sainath as its new chief technology officer, effective immediately. The chief technology officer position is newly created, and Sainath will lead the Orangeburg, S.C.-based polymer extrusion and catheter manufacturing company's efforts to accelerate innovation and leverage the advanced capabilities of its … [Read more...] about Zeus names first chief technology officer
Concept Medical wins FDA IDE for MagicTouch AVF drug-coated balloon
Concept Medical today announced it received FDA investigational device exemption for its MagicTouch AVF Sirolimus drug-coated balloon (DCB) catheter. The IDE allows the Tampa, Florida-based company to start a clinical study to treat stenotic lesions of arteriovenous fistula (AVF) in the hemodialysis management of chronic renal failure. "This … [Read more...] about Concept Medical wins FDA IDE for MagicTouch AVF drug-coated balloon
Surmodics launches new medical device coating technology
Surmodics (Nasdaq:SRDX) announced today that it launched its most advanced hydrophilic medical device coating technology. Eden Prairie, Minnesota-based Surmodics designed the Preside coatings to complement its existing Serene hydrophilic coatings. Preside offers a unique, low-friction and low-particulate generation coating. It further enhances … [Read more...] about Surmodics launches new medical device coating technology
Cook Medical has more hydrophilic PTA balloon catheter options
Cook Medical today announced more sizes and locations for the Advance Serenity hydrophilic PTA balloon catheter product line. It's now possible for U.S. and Canadian interventionalists to use Advance Serenity for below-the-knee and above-the-knee procedures to treat patients with peripheral artery disease (PAD), according to Cook Medical. In … [Read more...] about Cook Medical has more hydrophilic PTA balloon catheter options