The Teleflex (NYSE: TFX) Freesolve RMS (resorbable magnesium scaffold) has won FDA Breakthrough Device designation for percutaneous coronary intervention (PCI). "Freesolve RMS has the potential to provide physicians with an additional treatment option, by reducing the need for permanent implants and potentially offering an alternative to … [Read more...] about Teleflex wins Breakthrough Device designation for Freesolve resorbable scaffold
Coatings
Medtronic snags breakthrough designation for below-the-knee drug-coated balloon
Medtronic (NYSE:MDT) has secured a breakthrough designation from the FDA for a version of its drug-coated balloon aimed at unblocking arteries below the knee, following years of development. The In.Pact BTK catheter is slated for an international, randomized pivotal trial that plans to enroll about 400 participants with peripheral artery disease … [Read more...] about Medtronic snags breakthrough designation for below-the-knee drug-coated balloon
Convatec launches new hydrophilic option for self-catheterization
Convatec is adding to its Cure family of self-administered urinary catheters, with a new model launching in the U.S. and Canada this month. The Cure Aqua is a ready-to-use intermittent catheter featuring a hydrophilic coating that the company says lowers friction and requires no activation steps. With opaque and easy-open packaging for greater … [Read more...] about Convatec launches new hydrophilic option for self-catheterization
Cordis earns FDA nod for Selution SLR drug-eluting balloon
Cordis earned FDA approval for its Selution SLR (sustained limus release) drug-eluting balloon (DEB) to treat coronary in-stent restenosis, the device developer announced today. “As the first and only sirolimus drug-eluting balloon approved in the United States, Selution SLR DEB introduces a groundbreaking therapy for the treatment of coronary … [Read more...] about Cordis earns FDA nod for Selution SLR drug-eluting balloon
Airiver treats first patient in drug-coated balloon study for chronic rhinosinusitis
Airiver Medical today announced the successful treatment of the first patient in a pivotal clinical trial of its drug-coated balloon (DCB). The first patient received treatment for chronic rhinosinusitis (CRS) in its RESTORE-2 U.S. pivotal clinical trial. It evaluates the Brooklyn Park, Minnesota-based company's Airiver ESSpand sinus DCB. Dr. … [Read more...] about Airiver treats first patient in drug-coated balloon study for chronic rhinosinusitis
Endologix acquires Pounce thrombectomy system from Surmodics
Endologix announced today that it acquired the Pounce thrombectomy system from Surmodics, closing the deal on May 18. Pounce, an FDA-cleared and commercially available fully mechanical thrombectomy platform, offers the non-surgical removal of thrombi and emboli from peripheral arteries. It comes in multiple configurations to support use across a … [Read more...] about Endologix acquires Pounce thrombectomy system from Surmodics
Medtronic has strong 1-year results for drug-coated balloon
Medtronic (NYSE:MDT) today announced new real-world data from a post-approval study of its In.Pact AV drug-coated balloon (DCB). The IN.PACT AV Access post-approval study demonstrated strong safety and effectiveness for the DCB in the treatment of arteriovenous fistula (AVF) stenoses in patients with end-stage kidney disease on dialysis. The … [Read more...] about Medtronic has strong 1-year results for drug-coated balloon
Airiver Medical wins FDA breakthrough nod for drug-coated balloon, treats first patient
Airiver Medical announced today that it received FDA breakthrough device designation for its pulmonary drug-coated balloon (DCB). Additionally, Airiver announced the first treated patients in a clinical trial for the DCB. The Brooklyn Park, Minnesota-based company designed its DCB to treat central airway stenosis. Central airway stenosis … [Read more...] about Airiver Medical wins FDA breakthrough nod for drug-coated balloon, treats first patient
Freudenberg Medical launches new hydrophilic coating solution
Freudenberg Medical announced today that it launched Lubriteq, its new high-performance hydrophobic coating solution. The Beverly, Massachusetts-based company also launched a comprehensive suite of associated development and manufacturing services. It now offers Lubriteq globally across its vertically integrated operations. Freudenberg said … [Read more...] about Freudenberg Medical launches new hydrophilic coating solution
Airiver Medical wins FDA IDE for pulmonary drug-coated balloon
Airiver Medical announced today that it received FDA investigational device exemption (IDE) for its pulmonary drug-coated balloon (DCB). The Brooklyn Park, Minnesota-based company designed its DCB to treat central airway stenosis. This FDA IDE – the company's first — allows it to begin a pivotal clinical trial of the technology. Central airway … [Read more...] about Airiver Medical wins FDA IDE for pulmonary drug-coated balloon
