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Stents

Advanced NanoTherapies closes $7.2M Series A for drug-coated balloon

June 28, 2022 By Sean Whooley

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 […]

Filed Under: Business/Financial News, Cardiovascular, Drug-Device Combinations, Drug-Eluting Stents, Funding Roundup, Pharmaceutical, Vascular Tagged With: Advanced NanoTherapies

Endologix reports positive results from percutaneous bypass trial

June 23, 2022 By Sean Whooley

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 […]

Filed Under: Catheters, Clinical Trials, Stents, Vascular Tagged With: Endologix

Boston Scientific to acquire majority stake in M.I. Tech

June 15, 2022 By Sean Whooley

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 […]

Filed Under: Business/Financial News, Endoscopic, Featured, Mergers & Acquisitions, News Well, Stents, Urology Tagged With: Boston Scientific, M.I. Tech

First patient enrolled in MedAlliance’s drug-eluting balloon trial

June 8, 2022 By Sean Whooley

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 […]

Filed Under: Cardiovascular, Clinical Trials, Drug-Device Combinations, Drug-Eluting Stents, Vascular Tagged With: MedAlliance

Getinge’s Atrium Medical has a Class I recall over covered stents

June 2, 2022 By Danielle Kirsh

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 […]

Filed Under: Cardiovascular, Catheters, Featured, News Well, Stents Tagged With: Atrium Medical

FDA grants IDE for MedAlliance’s sirolimus-eluting balloon

May 26, 2022 By Sean Whooley

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.

Filed Under: Cardiovascular, Drug-Device Combinations, Drug-Eluting Stents, Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: FDA, MedAlliance

Medtronic’s Resolute Onyx drug-eluting stent demonstrates strong safety, efficacy

May 18, 2022 By Sean Whooley

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 […]

Filed Under: Cardiac Implants, Cardiovascular, Clinical Trials, Drug-Device Combinations, Drug-Eluting Stents, Featured, Implants, News Well, Stents, Structural Heart, Vascular Tagged With: Medtronic

FDA approves Medtronic’s Onyx Frontier drug-eluting coronary stent

May 13, 2022 By Sean Whooley

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 […]

Filed Under: Cardiac Implants, Cardiovascular, Catheters, Drug-Device Combinations, Drug-Eluting Stents, Featured, Food & Drug Administration (FDA), Regulatory/Compliance, Stents, Structural Heart, Vascular Tagged With: FDA, Medtronic

Abbott announces availability of Xience Skypoint drug-eluting stent in extended sizes

May 12, 2022 By Sean Whooley

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 […]

Filed Under: Business/Financial News, Cardiac Implants, Cardiovascular, Catheters, Drug-Device Combinations, Stents, Structural Heart, Vascular Tagged With: Abbott

Silk Road Medical grows sales 27% in Q1 results

May 6, 2022 By Danielle Kirsh

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 […]

Filed Under: Business/Financial News, Cardiovascular, Catheters, MassDevice Earnings Roundup, Stents, Wall Street Beat Tagged With: Silk Road Medical

18 of the world’s most innovative medical technologies

April 26, 2022 By Danielle Kirsh

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 […]

Filed Under: Cardiac Implants, Cardiovascular, Catheters, Diabetes, Diagnostics, Digital Health, Endoscopic, Featured, Imaging, Implants, Neuromodulation/Neurostimulation, Oncology, Orthopedics, Patient Monitoring, Replacement Heart Valves, Stents, Structural Heart Tagged With: Abbott, Alcon, Biosense Webster, Boston Scientific, Devices4Care, Diatropix, Genmab, Germitec, Hexacath, Johnson & Johnson, Medtronic, Moveo, nanobiotix, Prix Galien International, Siemens Healthineers, sysmex, The Galien Foundation, The Hubrecht Institute, Urgo Medical, VRelax

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