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 […]
Stents
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 […]
Ariste Medical co-founder sees great potential for drug-coated implants and orthopedics
It’s been more than a decade since Lisa Jennings launched not one but two companies in the Great Recession. In 2020, she sold CirQuest Labs to MLM Medical Labs, where Jennings serves as chief scientific officer and managing director of U.S. operations. More recently, her pre-commercial medtech development startup, Ariste Medical, won FDA 510(k) approval for […]
Boston Scientific pouring €100M into Irish campus
Boston Scientific (NYSE:BSX) has unveiled plans for a €100 million ($118 million) expansion of its operations outside Galway, an Irish economic development agency announced today. IDA Ireland said the project will create more than 300 jobs in the coming years. The construction project will create more than 40,000 ft2 of carbon-neutral medical device manufacturing space […]
Silk Road Medical grows sales 33% in Q4
Silk Road Medical (NSDQ:SILK) posted fourth-quarter results that beat the revenue consensus on Wall Street and missed on earnings estimates. The Sunnyvale, California-based stroke treatment tech company reported losses of -$14.7 million, or -42¢ per share, on sales of $28.3 million for the three months ended Dec. 31, 2021, for a bottom-line gain of 12.3% […]
FDA clears Dyad Medical automated cardiac image analysis platform
Dyad Medical this week announced that it received FDA 510(k) clearance for its Libby IAAA cardiac image analysis platform. Boston-based Dyad Medical designed the Libby IAAA for image analysis used for viewing and quantifying intravascular optical coherence tomography (IVOCT) images. It allows healthcare professionals to automate intravascular investigation and see inside of blood vessels to […]