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 […]
Vascular
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 […]
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. Adjusted to exclude 1-time items, earnings per […]
Bellerophon shares fall despite Street-beating Q2 results
Shares in Bellerophon Therapeutics (NSDQ:BLPH) fell today even though the company beat expectations on Wall Street with its second quarter results. The Warren, N.J.-based company posted a net loss of -$3.9 million with no sales for the 3 months ended June 30, for bottom-line growth of 23% compared with the same period last year. Adjusted to […]
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 […]
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 that while the […]
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. […]
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. “The Stellarex DCB has shown safety and efficacy in a cohort of patients which included a higher preponderance of diabetics […]
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. “By providing a head-to-head comparison […]
Resolute Onyx drug-eluting stent launches in Japan
Medtronic (NYSE:MDT) said this week that it’s Resolute Onyx drug-eluting stent will launch in Japan on July 10th. The device’s predecessor, Resolute Integrity, began selling in Japan in August 2012. The drug-eluting stent has a metallically dense, radiopaque inner core within the cobalt alloy wire to boost visibility for accurate placement, according to Medtronic. The stent […]