Members of an FDA advisory panel yesterday cited conflicting evidence from studies of paclitaxel-eluting devices in treating peripheral artery disease, with the panel’s chairman calling the data “a smoking gun, but no bullet or dead bodies at this particular point.” A meta-analysis published in the Journal of the American Heart Assn. last December suggested that PAD patients treated with paclitaxel-coated […]
Drug-Eluting Stents
FDA: More data needed on paclitaxel devices
More data is needed on devices that elute the drug paclitaxel to determine if they pose a higher mortality risk than non-eluting devices in treating peripheral artery disease, the FDA said ahead of an advisory panel meeting today. A meta-analysis published in the Journal of the American Heart Assn. last December suggested that PAD patients treated with paclitaxel-coated balloons […]
U.K. says doctors should limit use of paclitaxel devices
U.K. medtech regulators have recommended a ban on routine use of paclitaxel drug-coated balloons (DCBs) and drug-eluting stents in patients with intermittent leg cramps, but held back on recommending the same for patients with critical limb ischemia. U.S., U.K. and French regulators began raising concerns about the risk of increased long-term mortality in people with […]
Sterilization plant closures: Here’s why you need to care
The recent shutdown of a Sterigenics medical device sterilization plant in Willowbrook, Ill. has affected medtech giants such as Becton Dickinson (NYSE:BDX), Boston Scientific (NYSE:BSX), Medtronic (NYSE:MDT), Smith & Nephew (NYSE:SNN) and Stryker (NYSE:SYK), according to an FDA list of devices processed at the sterilization plant. Medium-sized and smaller firms, including Teleflex (NYSE:TFX), Arthrex and ArthroCare also had devices processed there. The Willowbrook plant sterilized 594 types of devices, including sutures, clamps, […]
Medtronic wins expanded FDA indication for Resolute DES
Medtronic (NYSE:MDT) said today that it won expanded FDA approval for its Resolute drug-eluting stent platform, now cleared for treating patients with coronary artery disease and de novo chronic total occlusion. The new clearance covers the Resolute Onyx and Resolute Integrity devices, the Fridley, Minn.-based company said. Read the whole story on our sister site, Drug Delivery […]
Biotronik wins FDA nod for Orsiro DES
Biotronik said today that it won FDA approval for its for its Orsiro drug-eluting stent, touting it as the first and only ultrathin DES to outperform Abbott‘s (NYSE:ABT) Xience. The Berlin, Germany-based company said that the approval came based on data from the BIOFLOW-V pivotal trial of the device. Results from the study indicated a significantly […]
Investigators hit pause on trials following concerns over paclitaxel-coated devices
A meta-analysis published in the Journal of the American Heart Association last week suggested that patients treated with paclitaxel-coated balloons and stents for peripheral artery disease could be at a higher risk for late death compared to people treated with uncoated balloons. The results of the study prompted investigators for two trials to stop their studies. Meanwhile, leaders in […]
Boston Scientific CEO talks pricing pressure for drug-eluting stents
On an earnings call with analysts this week, Boston Scientific (NYSE:BSX) CEO Mike Mahoney touted the momentum of his company’s drug-eluting stent portfolio but noted that the technologies continue to face headwinds in the U.S. thanks to pricing pressure. The Mass.-based company reported third-quarter profits of $432 million, or 31¢ per share, on sales of $2.39 billion […]
Study: U.S. hospitals charged more for implantable cardiac devices
The prices of similar cardiac implants in the U.S. were higher than in the four largest E.U. markets between 2006 and 2014, according to a new study by British researchers. U.S. prices were two to six times higher than those in Germany and varied widely among the European countries studied. The study, published in the journal […]
TCT 2018: Boston Scientific wins FDA nod for drug-eluting vascular stent
On the heels of positive study results at the 30th Transcatheter Cardiovascular Therapeutics meeting, Boston Scientific (NYSE:BSX) won FDA approval for its drug-eluting vascular stent system, Eluvia. The device, which is designed for the treatment of peripheral artery disease, uses a drug-polymer combination to deliver paclitaxel over the course of a year. Get the full story at our […]
Medtronic launches one-month DAPT study for drug-eluting stent in U.S., Japan
Medtronic (NYSE:MDT) said today that it’s launching a study in the U.S. and Japan to evaluate dual antiplatelet therapy in high bleeding risk patients implanted with the Resolute Onyx drug-eluting stent during percutaneous coronary intervention. The company’s Onyx One Clear study is one of the first designed to assess the risk of cardiac death and stent […]