Endologix today said it received FDA approval for its Alto Abdominal Stent Graft System. The company said it received approval based on its regulatory submission that included results from its Elevate Investigational Device Exemption clinical study. Under the terms of the FDA approval, the first 100 patients after commercial launch will be included in a […]
Supira Medical closes $35m Series B for its pVAD tech
Supira Medical announced that it closed a $35 million Series B financing round and appointed Nitin Salunke as its new president & CEO. Cormorant Asset Management led the financing, which officially closed on Feb. 25. The Capital Partnership, 415 Capital, AMED Ventures and Shifamed Angels all participated as well. Campbell, Calif.-based Supira Medical said in […]
FDA clears Cleveland Clinic 3D-printed airway stents
The FDA recently cleared 3D-printed, patient-specific stents developed by a doctor at the Cleveland Clinic. Cleveland Clinic physician Tom Gildea developed the stents to keep open the airways of patients with serious breathing disorders caused by inflammation, trauma, tumors and other masses. Airway stents come in a limited number of sizes and shapes and are […]
Reflow Medical wins FDA breakthrough nod for Temporary Spur Stent System
Reflow Medical announced yesterday that its Temporary Spur Stent system for treating below-the-knee peripheral artery disease (PAD) won FDA breakthrough device designation. The Temporary Spur Stent system includes radially expandable spikes designed to create multiple pathways for delivering antiproliferative drugs for increased uptake into the vessel wall for facilitating acute luminal gain without leaving anything […]
Medinol stent performs just as well as Medtronic Resolute, study says
The EluNIR drug-eluting stent made by Medinol performed just as well as the Resolute Integrity or Resolute Onyx stents from Medtronic (NYSE:MDT), according to new clinical study results from an international team of researchers. The randomized clinical trial — conducted by researchers from the U.S., Israel, Canada and the Netherlands — involved 2,221 people and compared […]
Report: Mayo Clinic to try Corindus telestenting
Mayo Clinic researchers this spring plan to try out Corindus’ telestenting technology — which Mayo officials think could improve care in the rural hospitals in their network, according to a report in the Star Tribune of Minneapolis. Corindus told MassDevice‘s sister site Medical Design & Outsourcing in 2018 that the company had a partnership with […]
Stent makers point to quality-of-life findings by massive federal study
The giant federal study that found the use of stents in stable heart-disease patients is no better than drugs to treat clogged arteries reached another, less-hyped conclusion. Manufacturers of stents for percutaneous coronary intervention (PCI) note that the Ischemia study also concluded that patients who undergo a stenting procedure have a better quality of life. They suffer […]
Study: Stents no better than drugs for stable heart disease
This article has been updated with stock market results and comments from Medtronic. A major new study has concluded that the use of stents in stable heart disease patients is no better than drugs to treat clogged arteries. Results of the Ischemia study were released at the American Heart Association annual meeting in Philadelphia on Saturday. The […]
China approves Biotronik’s Orsiro drug-eluting stent
Biotronik said today that China’s National Medical Products Administration approved its Orsiro drug-eluting stent. Orsiro is a cobalt-chromium stent that elutes the drug sirolimus via the Berlin-based company’s Biolute bioabsorbable polymer coating. Biotronik said it plans to have Orsiro on the Chinese market “in the coming months.” Get the full story at our sister site, […]
BD warns of international device shortages in EO plant legal filing
The Georgia environmental chief’s effort to shut down a Becton Dickinson (NYSE:BDX) medtech sterilization plant could cause widespread shortages of commonly used devices for which BD has a large market share, the company said today in a court filing. On Tuesday, Georgia state Environmental Protection Division director Richard Dunn filed a motion with Newton County Superior Court […]
FDA warns of device shortages again due to sterilization plant closures
The FDA today warned of “years of spot or nationwide shortages” of a number of surgical kits and implantable medical devices due to the closure of two medtech sterilization plants that use ethylene oxide (EO) and efforts in Georgia to close a third. Potentially affected surgical kits include those used in emergency Caesarean sections and […]
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