Medtronic (NYSE:MDT) announced that it received FDA approval for its In.Pact 018 paclitaxel-coated balloon catheter. Fridley, Minnesota-based Medtronic’s In.Pact 018 paclitaxel-coated percutaneous transluminal angioplasty (PTA) balloon catheter, a drug-coated balloon product, received an indication for the interventional treatment of peripheral arterial disease (PAD) in the superficial femoral and popliteal arteries. According to a news release, […]
Vascular
FDA grants IDE for MedAlliance’s sirolimus-eluting balloon
MedAlliance announced today that it received FDA investigational device exemption (IDE) for its Selution SLR drug-eluting balloon. Geneva, Switzerland-based MedAlliance designed its Selution SLR (sustained limus release) novel sirolimus-eluting balloon to provide a controlled sustained drug release, similar to a drug-eluting stent. Selution SLR features unique micro-reservoirs made of biodegradable polymer intermixed with sirolimus. The […]
Medtronic’s Resolute Onyx drug-eluting stent demonstrates strong safety, efficacy
Data presented today at the EuroPCR 2022 event supported the use of the Medtronic (NYSE:MDT) Resolute Onyx drug-eluting stent. University of Padua Medical School Head of Interventional Cardiology Dr. Giuseppe Tarantini presented late-breaking clinical trial results from the investigator-initiated, Medtronic-funded ROLEX (Revascularization Of LEft Main With Resolute onyX) registry. ROLEX, the largest real-world, multicenter prospective […]
FDA approves Medtronic’s Onyx Frontier drug-eluting coronary stent
Medtronic (NYSE:MDT) announced today that it received FDA approval for its Onyx Frontier drug-eluting stent (DES). Onyx Frontier, the latest iteration of Medtronic’s Resolute DES family, was designed to leverage the same stent platform as Resolute with an enhanced delivery system for improving deliverability and increasing acute performance, even in the most challenging of cases. […]
Abbott announces availability of Xience Skypoint drug-eluting stent in extended sizes
Abbott (NYSE:ABT) announced today that its Xience Skypoint drug-eluting stent platform is now available globally. Xience Skypoint has received FDA approval, the CE mark, and PMDA approval in Japan for the broadest expansion with the availability of extended sizes of 4.5 mm and 5 mm offerings. According to Abbott, Xience Skypoint stents are now the […]
ICU Medical beats The Street in Q1
ICU Medical (Nasdaq:ICUI) reported first-quarter results that came in ahead of the consensus earnings per share forecast. The San Clemente, California-based company yesterday evening posted losses of $38.1 million, or $1.61 per share, on sales of $543.1 million for the three months ended March 31, 2022, for a bottom-line slide into the red on sales […]
Medtronic issues voluntary recall for certain In.Pact drug-coated balloon catheters
Medtronic (NYSE:MDT) announced today that it voluntarily recalled a subset of its In.Pact Admiral and In.Pact AV balloon catheters. The company initiated the recent recall of the paclitaxel-coated percutaneous transluminal angioplasty (PTA) balloon catheters due to the potential for pouch damage resulting in a loss of sterility. According to the company, approximately 6,000 In.Pact Admiral […]
PAVmed completes first-in-human implantations of its intraosseous infusion system
PAVmed (Nasdaq:PAVM) has successfully completed the first human implants of its PortIO intraosseous infusion system, the company said today. New York-based PAVmed designed its PortIO system with an implantable intraosseous vascular access device and insertion kit. Instead of a catheter located in a vein, the system has a short extension from the device inserted by […]
Cook Medical wins FDA breakthrough designation for new drug-eluting stent
Cook Medical recently announced that it received FDA breakthrough designation for its drug-eluting stent for below the knee. Bloomington, Indiana-based Cook Medical designed the stent to treat patients who have chronic limb-threatening ischemia (CLTI). Get the full story on our sister site, Medical Tubing + Extrusion.
ICU Medical’s Smiths Medical acquisition remains on track
ICU Medical (NASDAQ:ICUI) is a step closer to acquiring Smiths Medical after clearing a shareholders vote at Smiths’ British parent company, the Smiths Group. Almost all of the nearly 327 million Smiths Group shareholders voting on November 17 approved the $2.35 billion buy. Get the full story on our sister site Medical Tubing + Extrusion.