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 […]
Vascular
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.
MedAlliance touts 18-month data for treating lesions with sirolimus-eluting balloon
MedAlliance today touted late-breaking clinical trial data demonstrating positive outcomes with its Selution SLR drug-eluting balloon. The company presented 18-month results from its Prestige below-the-knee (BTK) study evaluating the safety and performance of Selution SLR in treating long tibial occlusive lesions (TASC C & D) in patients with critical limb ischemia (CLI) at VIVA21. According to a […]
MedAlliance completes trial enrollment for sirolimus-eluting balloon for treating PAD
MedAlliance announced today that it completed patient enrollment for a trial of its Selution SLR sirolimus drug-eluting balloon. Geneva, Switzerland-based MedAlliance, along with Japanese partner MDK Medical, completed the enrollment following the acceptance of a Clinical Trial Notification (CTN) by the Pharmaceutical Products and Medical Devices Agency (PMDA) of Japan in June 2020. The study […]
Sinomed launches HT Supreme drug-eluting stent in Europe
Sinomed has completed the first commercial implantation of its HT Supreme drug-eluting stent in Ireland. Faisal Sharif, professor of translational cardiovascular medicine and innovation at the National University of Ireland Galway, successfully performed the first procedure with HT Supreme, a healing-targeted drug-eluting stent designed to treat patients with narrowing or blockages to their coronary arteries. […]
MedAlliance closes enrollment for sirolimus-coated balloon trial
MedAlliance announced today that it closed patient enrollment for its clinical trial of the Selution SLR 018 BLF drug-eluting balloon. Nyon, Switzerland–based MedAlliance designed its Selution SLR 018 BLF for the treatment of patients with disease below the knee. The company touts Selution SLR as the first device of its kind to receive an “innovative […]
