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 […]
FDA grants breakthrough status to CorFlow’s CoFI device
CorFlow Therapeutics said yesterday that it won breakthrough device designation from the FDA for its Cofi device. Baar, Switzerland-based Corflow’s controlled flow infusion system is is designed to both assess coronary microcirculation after percutaneous coronary intervention procedures, including stenting, and to control the delivery of drugs to the smaller blood vessels not address by the […]
Controversy erupts over stenting study
Controversy reportedly erupted at a European cardiovascular society conference this week after a prominent cardiologist accused the study’s investigators of manipulating the trial to skew the results. Five-year data from the Excel trial, released last month at the Transcatheter Cardiovascular Therapies conference, showed that percutaneous coronary intervention was as good as coronary artery bypass grafts […]
FDA OKs PQ Bypass trial of Torus peripheral stent graft
PQ Bypass said today that it won full FDA approval of its investigational device exemption trial for the Torus stent graft for treating peripheral artery disease. The Torus stent graft is designed to treat PAD in the superficial femoral artery by aiding in halting the progression of the disease, rather than solely treat the symptoms, […]
TCT 2019: Medtronic’s Resolute Onyx non-inferior to Biosensors Biofreedom stent
A study comparing the Resolute Onyx drug-eluting stent from Medtronic (NYSE:MDT) and the BioFreedom stent made by Biosensors International (PINK:BSNRY) showed the Medtronic device to be non-inferior in patients on a one-month dual anti-platelet therapy regimen, according to results presented yesterday at the annual Transcatheter Cardiovascular Technologies conference in San Francisco. Medtronic launched the 2,000-patient study […]
Japan OKs OrbusNeich’s Combo Plus stent
OrbusNeich Medical today said it won market approval in Japan for its Combo Plus coronary stent. The Combo Plus stent is designed to address the risk of stent thrombosis associated with delayed healing in conventional drug-eluting stents. The Combo Plus DES uses endothelial progenitor cell capture technology and abluminal sirolimus drug elution delivered from a biodegradable […]
Merit Medical closes $50m BrightWater buyout
BrightWater Medical said today that it completed the sale of the organization to Merit Medical (NSDQ:MMSI), three months after Merit made its $50 million offer. In June, Merit valued the acquisition at $35 million upfront with a further $15 million in potential payments contingent upon CE Mark approval and meeting future sales targets. Temecula, Calif.-based BrightWater’s […]
CryoLife, EndoSpan ink distribution deal
CryoLife Inc. (NYSE:CRY) today announced that it has signed a strategic distribution and credit facility agreement with Endospan with an option to purchase the company. Kennesaw, Georgia-based CryoLife will have exclusive distribution rights to Endospan’s Nexus stent graft system in Europe. CryoLife will pay $10 million upfront and provide up to $15 million in debt financing […]
Cook Medical touts paclitaxel-coated stent PAD study results
Cook Medical today touted five-year data from a study into the use of its Zilver PTX paclitaxel-coated stent for peripheral arterial disease (PAD). The study concluded that there was no increase in long-term all-cause mortality due to paclitaxel after treatment using the Zilver PTX stent compared to traditional angioplasty or a bare-metal stent, according to […]
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