Biotronik said today that its Orsiro drug-eluting stent beat Abbott‘s (NYSE:ABT) Xience DES in a trial comparing the target lesion failure rates of both devices. The data, which were presented at the European Society of Cardiology’s ESC Congress and published by The Lancet, showed a 6.2% TLF rate at 12-months for patients treated with Orsiro compared to 9.6% […]
Vascular
Xarelto, aspirin combo reduces risk of cardiovascular events in pivotal Ph3 trial
Johnson & Johnson (NYSE:JNJ) subsidiary Janssen touted data today from a pivotal Phase III trial showing that Xarelto plus aspirin reduced the risk of major cardiovascular events in patients with stable coronary and peripheral artery disease compared to aspirin alone. Treatment with Xarelto twice per day and aspirin once-daily cut the risk of major cardiovascular events […]
Philips, HeartFlow ink co-selling, co-dev deals
Royal Philips (NYSE:PHG) said today it inked a collaborative deal with HeartFlow to promote HeartFlow’s FFRct Analysis system along with Philips’ catheters for assessing coronary arteries in patients with suspected coronary artery disease. HeartFlow’s FFRct fractional flow reserve software is designed to aid in the diagnosis and treatment of patients with suspected coronary artery disease, providing insight […]
Bard lands new indication for its drug-coated balloon
C. R. Bard(NYSE:BCR) said today that its Lutonix 035 drug-coated balloon PTA catheter won premarket approval from the FDA and is available in the U.S. The company’s Lutonix 035 device is the first drug-coated balloon approved in end-stage renal disease patients with stenotic lesions in dialysis arteriovenous fistulae. Bard’s DCB is also approved to treat […]
Ra Medical CEO Irwin aims for Feb 2018 IPO
In May, Ra Medical received a nod from the FDA for its Dabra arteriosclerosis laser, clearing it for use in the US. It was a decision the company had been waiting on for approximately 3 years, CEO Dean Irwin told MassDevice.com in an interview, and signaled a significant shift forward. “In 2014, we submitted to the FDA, […]
FDA approves Malin’s Hourglass peripheral embolization plug
Irish life sciences company Malin Corp said today it won FDA 510(k) clearance for its Hourglass peripheral embolization plug. The company said the Hourglass plug is designed to be deployed over-the-wire for peripheral embolization procedures, and can provide immediate occlusion with a single integrated device. “This is the 1st integrated, over-the-wire device designed for peripheral […]
Study: New infrared imaging technique could help detect heart attack, stroke risk
A new near-infrared diagnostic technique could help improve early detection for patients at risk of heart attacks or strokes, according to a new multi-center study. Researchers at the University of Warwick’s WMG, the Baker Institute and Monash University reported that when they increased the wavelength of light currently used to visualize athereosclerotic plaques, they were […]
Endologix touts data from AFX, AFX 2 aortic stent graft trial
Endologix (NSDQ:ELGX) touted data today from its Leopard clinical trial, which compared Endologix’s AFX and AFX2 endografts to other commercially available bifurcated aortic endografts. The trial, which launched in 2015, has since enrolled 458 patients. The study’s primary endpoint is freedom from aneurysm-related complications, including aneurysm rupture, conversion to open repair and endoleaks. Freedom from ARC […]
Cook Medical recalls select Zenith Alpha endo grafts
The FDA today released information on a recall of Cook Medical’s Zenith Alpha thoracic endovascular graft designed for treating blunt traumatic aortic injury over issues with thrombus formation, classifying the recall as Class I. Class I recall designations, the FDA’s most serious classification of recall, are used when there is a reasonable probability that product use […]
Pavmed beats Q2 EPS by a penny
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 […]
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 […]