UPDATED May 20, 2016, with more results out of Paris. St. Jude Medical (NYSE:STJ) announced it won CE Mark approval in the European Union for its PressureWire X Guidewire fractional flow reserve measurement system and is launching the product in Europe. The company announced the launch and clearance at the EuroPCR meeting in Paris this week. […]
Drug-Eluting Stents
Biotronik launches Orsiro drug-eluting stent trial
Biotronik said today it enrolled the 1st patient in its BiostemI trial looking to compare the safety and efficacy of its Orsiro hybrid drug-eluting stent with Abbott‘s (NYSE:ABT) Xience Xpedition in treating ST-segment elevation myocardial infarction. The company is touting the trial as the largest investigator-initiated study pitting the Orsiro stent against the Xience Xpedition. The randomized, […]
Medtronic touts more early data from drug-filled stent study | ACC 2016
Medtronic (NYSE:MDT) yesterday touted early data from a clinical study of its drug-filled stent aimed at winning CE Mark approval in the European Union. The DFS is built using the Fridley, Minn.-based medical device giant’s Resolute Integrity and Resolute Onyx stents, using its “continuous sinusoid” and CoreWire technologies. It’s made with a “tri-layer” wire design in which the innermost […]
Stentys wins CE Mark for Xposition S self-apposing coronary stent
Stentys SA (EPA:STNT) said today it won CE Mark approval in the European Union for its self-apposing coronary Xposition S sirolimus-eluting stent, claiming it to be the “world’s 1st and only self-apposing coronary stent.” The approval came based upon results from a study of the device published last year in the journal Catheterization and Cardiovascular […]
Medtronic wins expanded CE Mark for larger Resolute Onyx stent
Medtronic (NYSE:MDT) said today it won CE Mark approval in the European Union for a expanded indications and sizes for its Resolute Onyx drug-eluting stent. The Resolute Onyx device is based on Medtronic’s Resolute Integrity DES, but uses the Fridley, Minn.-based firm’s new CoreWire technology to wrap a cobalt alloy around a denser metal to increase […]
Svelte Medical granted CE Mark for Slender IDS drug-eluting stent catheter
Svelte Medical Systems said today it won CE Mark approval in the European Union for its Slender sirolimus-eluting coronary stent-on-a-wire integrated delivery system designed to treat coronary artery disease. The Slender IDS is the lowest-profile drug-eluting stent on the market, according to the New Providence, N.J.-based company. Approval in the EU came based on data […]
InspireMD pulls trigger on 10-for-1 reverse stock split
InspireMD (OTC:NSPR) said it pulled the trigger on a reverse 10-to-1 stock split with shareholders receiving 1 share of common stock for each 10 they own. The reverse split went into effect today for the Boston-based stent maker, according to a press release. In response, Inspire shares are down 11.8% to $1.45 in mid-day trading. The […]
Reva finishes CE trial enrollment for drug-eluting scaffold
Reva Medical (ASX:RVA) said it finished enrollment in its CE clinical trial of its Fantom siolimus-eluting bioresorbable scaffold for patients being treated for coronary artery disease. Data from the 110-patient Fantom II trial will be used for the company’s CE Mark application in the European Union, which the company said it is hopeful to submit in […]
Stentys wins CE Mark for BTK drug-eluting stent
Stentys SA (EPA:STNT) said yesterday it won CE Mark approval in the European Union for its drug-eluting stent for treatments of below-the-knee arteries. The self-expanding, drug-eluting stent is the 1st of its kind with regulatory approval in Europe for BTK arteries, according to the French company. “Entering the peripheral arterial disease market, which, outside of […]
PAD: Boston Scientific touts Eluvia trial data
Boston Scientific (NYSE:BSX) said today that a 12-month study of its Eluvia drug-eluting stent reported a primary patency of 96%, which the company claims is the highest reported for a femoropopliteal artery lesion treatment for patients with peripheral artery disease. The palitaxel-coated Eluvia stent is the 1st stent designed to be deployed in the superficial femoral […]
Abbott’s Absorb fares well again against Xience in Japanese study
Abbott (NYSE:ABT) today released positive data from a Japanese study of its Absorb fully dissolving heart stent that pitted it against its own Xience permanent drug eluting stent. The results were announced at the European Society of Cardiology’s annual meeting in London. The 400 patient multi-center, randomized Absorb study, published in the European Heart Journal, set […]