Abbott (NYSE:ABT) touted two-year data yesterday from its trial designed to compare the company’s HeartMate 3 left ventricular assist device to its HeartMate 2 device in patients with advanced heart failure. Data from the study were published in The New England Journal of Medicine and presented at the American College of Cardiology’s 67th Annual Scientific Session. More […]
Cardiovascular Systems (NSDQ:CSII) said today that the FDA granted 510(k) clearance to the OrbusNeich‘s 1mm Sapphire II Pro coronary balloon. St. Paul, Minn.-based Cardiovascular Systems touted the newly cleared product as the first and only 1mm coronary balloon available in the US. “Offering the Sapphire II Pro 1.0mm coronary balloon—the smallest, FDA-cleared coronary balloon on the market—is […]
Cardiovascular Systems (Nasdaq: CSII) announced today that it is expanding its product portfolio through new partnerships with OrbusNeich and Integer. The OrbusNeich partnership makes St. Paul, Minn.–based CSI the exclusive U.S. distributor of Hong Kong–based OrbusNeich‘s balloon products. The deal with Frisco, Texas–based Integer (NYSE: ITGR) involves Integer producing CSI-branded Zilient guidewires. Get the full story on our sister site Medical […]
At this year’s Transcatheter Cardiovascular Therapeutics meeting, companies presented work comparing shortened durations of dual anti-platelet therapy with the standard 1-year regimen in patients treated with a drug-eluting stent. Among those companies were Medtronic (NYSE:MDT) and OrbusNeich. Here’s a look at what they found. Get the full story at our sister site, Drug Delivery Business News.
OrbusNeich touted results today from a pivotal registration study comparing its Combo dual therapy stent with Abbott‘s (NYSE:ABT) Xience stent in patients with ischemic heart disease. The trial is designed to evaluate the effectiveness of OrbusNeich’s combined endothelial progenitor cell capture and drug-eluting stent. The data showed that the device is non-inferior to Abbott’s drug-eluting stent after […]
OrbusNeich said today it won FDA 510(k) clearance for its Sapphire II Pro and Sapphire NC Plus balloon dilation catheters and launched the devices in the US. The Hong Kong-based company’s Sapphire II Pro features a sub-zero tapered tip and an ultra-low profile for entry through tight lesions, as well as a proprietary XR balloon for crossability […]
OrbusNeich said today that it launched the latest version of its dual-therapy stent, the Combo Plus, featuring an antibody biological coating designed to promote vessel healing in patients with complex coronary artery disease. After the stent is implanted, the biological coating captures endothelial progenitor cells and kicks off formation of an endothelial layer. A coating of bioabsorbable polymer […]
OrbusNeich said today it expanded its portfolio to include its Jade and Scoreflex percutaneous transluminal angioplastyballoon devices designed to treat peripheral artery disease. The balloon devices are OrbusNeich’s 1st foray into lower limb and arteriovenous fistula intervention, the Hong Kong-based company said. “Broadening our offering to include peripheral products is a natural progression for OrbusNeich. […]
OrbusNeich said today it launched a Chinese trial of its Combo dual-therapy coronary stent designed to repair vessel injury and regenerate endothelium. The 436-patient randomized, non-inferiority trial has enrolled its 1st patient, the Hong Kong-based company said, and will compare the Combo stent’s effectiveness against Lepu Medical‘s Nano stent for up to 5 years. “We […]
OrbusNeich Medical said today that it enrolled the 1st U.S. patient in a pivotal trial of its dual-therapy Combo stent.