Medical device maker Pavmed Inc. (NSDQ:PAVM) topped expectations on Wall Street with its second quarter results today. The New York-based company posted a net loss of -$989,707, or -8¢ per share, for the 3 months ended June 30, for bottom-line growth of 25% compared with the same period last year. Get the full story at our sister […]
Vascular
Cardiovascular Systems touts 1-year, sub-analysis data from Liberty PVI study
Cardiovascular Systems (NSDQ:CSII) today released both 1-year and a sub-analysis results from the Liberty 360 clinical trial of peripheral interventions, including those using its DiamondBack 360 coronary orbital atherectomy system. The 1,200 patient study aimed to evaluate acute and long-term clinical outcomes of peripheral interventions for patients with peripheral artery disease, with the most common device used […]
VC shops back CeloNova BioSciences
CeloNova BioSciences said today that it inked a 4-year financing deal with Congruent Investment Partners and SWK Holdings Corp. The funds are slated to support CeloNova’s ongoing clinical trials and product initiatives, including the launch of its Cobra PzF NanoCoated coronary stent. Get the full story at our sister site, Drug Delivery Business News.
7 medtech stories we missed this week: August 4, 2017
From MDCorp inking a European distribution deal to Align Technology’s North Carolina expansion, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. MDCorp inks distribution deal with Smart Endoscope Systems MDCorp announced in a July 31 press release that it has signed a distribution agreement with Smart Endoscope […]
Laminate Medical wins FDA IDE nod for VasQ fistula device trial
Laminate Medical Technologies said this week it won FDA investigational device exemption approval to launch a trial of its VasQ implanted blood vessel device designed for patients requiring arteriovenous fistulas as vascular access for hemodialysis. The Israel-based company’s VasQ device is designed to aid kidney failure patients in need of dialysis by providing external support […]
Gore touts reduced portal hypertension, complications in Viatorr Tips trial
W.L. Gore & Associates today released preliminary data from a trial of its Viatorr Tips endoprosthesis with controlled expansion, touting reduced portal hypertension treatment complications when compared to the company’s legacy Tips device and bare metal stents. Data from the study was presented at The International Liver Congress 2017 in Amsterdam, the Flagstaff, Ariz.-based company […]
Japan clears CardioFocus’ HeartLight
CardioFocus said today it won approval from the Japanese Ministry of Health, Labour and Welfare for its HeartLight endoscopic ablation system with an indication for treating paroxysmal atrial fibrillation. The Marlborough, Mass.-based company’s HeartLight system is designed to allow electrophysiologists to control the delivery of laser energy through direct visual guidance to isolate pulmonary veins with […]
Boston Scientific to end Renuvia bioresorbable coronary stent program
Boston Scientific (NYSE:BSX) is looking to terminate its Renuvia bioresorbable coronary stent program, according to a Minneapolis Star Tribune report. The move comes after new clinical studies of Abbott‘s (NYSE:ABT) Absorb bioresorbable stent indicated that use of the device resulted in a higher risk of serious adverse events compared to metal stents. Marlborough, Mass.-based Boston Scientific said […]
QT Vascular launches pivotal trial for drug-coated peripheral balloon
QT Vascular said today that it launched the U.S. pivotal trial for its Chocolate Touch drug-coated peripheral balloon in the hopes of winning FDA approval. The device won CE Mark clearance in September 2015. The trial is slated to compare the safety and effectiveness of the Chocolate Touch balloon with Bard‘s(NYSE:BCR) Lutonix drug-coated balloon catheter. The company […]
Spectranetics wins FDA nod for Stellarex DCB
Spectranetics (NSDQ:SPNC) said today that its Stellarex drug-coated balloon won FDA pre-market approval. The device is designed to treat patients with peripheral arterial disease, bringing blood flow back to the superficial femoral and popliteal arteries. Get the full story at our sister site, Drug Delivery Business News.
Surmodics to launch pivotal trial for drug-coated balloon
Surmodics (NSDQ:SRDX) said today that it won investigational device exemption from the FDA to launch a pivotal trial of its SurVeil drug-coated balloon. The trial is slated to compare the Eden Prairie, Minn.-based company’s device with Medtronic‘s (NYSE:MDT) In.Pact Admiral drug-coated balloon for patients with peripheral artery disease in the upper leg. Get the full story at our […]