Advanced NanoTherapies announced today that it closed an oversubscribed Series A equity financing round. Los Gatos, California-based Advanced NanoTherapies, which develops the SirPlux Duo drug-coated balloon (DCB) for treating de novo coronary artery disease (CAD) lesions, has now raised $12.5 million in total since September 2020. Get the full story at our sister site, Drug […]
Stents
Endologix reports positive results from percutaneous bypass trial
Endologix announced today that 12-month results from a trial of its Detour system demonstrated a low rate of complications. Irvine, California-based Endologix’s Detour 2 FDA investigational device exemption (IDE) study was designed to evaluate the safety and effectiveness of the Detour system for percutaneous bypass in the treatment of long-segment femoropopliteal disease. Get the full story […]
Boston Scientific to acquire majority stake in M.I. Tech
Boston Scientific (NYSE:BSX) announced today that it agreed with Synergy Innovation to purchase its majority stake in M.I. Tech. Marlborough, Massachusetts-based Boston Scientific will acquire a stake totaling approximately 64% in the publicly traded, Korea-based manufacturer and distributor of medical devices for endoscopic and urologic procedures. According to a news release, M.I. Tech created the […]
First patient enrolled in MedAlliance’s drug-eluting balloon trial
MedAlliance announced today that the first patient was enrolled in a trial of its Selution SLR sirolimus-eluting balloon. Last month, the company received FDA investigational device exemption (IDE) for the Selution SLR drug-eluting balloon, which it designed to provide a controlled sustained drug release, similar to a drug-eluting stent. The FDA IDE BTK (below-the-knee) Selution4BTK clinical trial […]
Getinge’s Atrium Medical has a Class I recall over covered stents
The FDA today determined that Atrium Medical’s recall of some of its iCast covered stents is Class I, the most serious kind. Hudson, N.H.–based Atrium Medical — a subsidiary of Swedish medtech giant Getinge — is recalling certain iCast covered stent systems due to complaints of separation of the balloon or catheter hub from the […]
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. Get the full story at our sister site, Drug Delivery Business News.
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 study, observed […]
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. Get […]
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, 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. Get the full story at our sister site, Drug Delivery Business […]
Silk Road Medical grows sales 27% in Q1 results
Silk Road Medical (NSDQ:SILK) this week posted first-quarter results that beat the revenue consensus on Wall Street and missed on earnings. The Sunnyvale, California-based stroke treatment tech company reported losses of $16.7 million, or -48¢ per share, on sales of $28.02 million for the three months ended March 31 for sales growth of 27% compared […]
18 of the world’s most innovative medical technologies
Judges this week are voting for the most innovative medical technologies among the nominees for the 2022 Prix Galien International Awards. The Prix Galien International Awards highlight the most innovative technologies in the life sciences industry. The New York-based Galien Foundation presents the international award to eligible nominees that have received a Prix Galien award […]
