Stents
Boston Scientific’s Promus Element stent wins additional CE Mark
Boston Scientific Corp. (NYSE:BSX) received CE Mark approval in the European Union for a new indication for its everolimus-eluting Promus Element coronary stent system.
Cardiologists may now deploy the platinum chromium alloy drug-eluting stents in patients with concomitant diabetes mellitus and in those experiencing an acute myocardial infarction, or heart attack.
Medtronic wins FDA approval for Integrity coronary stent
Medtronic Inc.’s (NYSE:MDT) Integrity coronary stent received pre-market approval from the Food & Drug Administration and logged its first U.S. implantation.
The Fridley, Minn.-based medical device giant based the bare-metal stent on its so-called "continuous sinusoid technology," which uses fewer welds than earlier stent models, such as the Driver, and a single wire of cobalt alloy.
Tryton drums up $20 million
Tryton Medical Inc. closed a $20 million Series D financing round.
The Durham, N.C.-based company said it plans to use the cash to fund a pivotal trial of its bifurcation lesion-treating stent in the U.S. and for its international marketing operation.
The balloon-expandable cobalt chromium-based "side branch stent" is designed to treat bifurcated lesions in cardiac arteries, according to a press release.
Medtronic achieves across the pond
Medtronic Inc. (NYSE:MDT) announced a pair of accomplishments for two of its cardiac treatment devices in Europe.
The Minneapolis-based medical device behemoth won CE Mark approval in the European Union for its CoreValve transcatheter aortic valve implantation system.
The company said the device, which has not yet been approved by the Food & Drug Administration for use in the U.S., increases the accuracy of the deployment of its CoreValve artificial aortic heart valve.
Study: African-Americans treated with drug-eluting stents at higher risk for blood clots
African-Americans have double the risk for blood clots after being treated with drug-eluting stents, according to a a study published in Circulation: Journal of the American Heart Assn.
In as few as 30 days, race was the strongest predictor for clotting after stents were implanted, the study showed.
The researchers analyzed data from 7,236 patients who, between mid-2003 through 2008, were treated with stents coated with clot-prevention drugs.
Cordis touts the 10-year anniversary of the first Cypher implantation
Cordis Corp. is touting the 10-year anniversary of the first implantation of a drug-eluting stent, saying a now-85-year-old patient showed nearly complete coverage a decade after receiving the first Cypher stent.
The Johnson & Johnson (NYSE:JNJ) subsidiary said a 75-year-old woman was implanted with the sirolimus-eluting device in 1999, to treat a single lesion in the left anterior descending artery. In 2009, angiography, IVUS examination and an optical coherence tomography test showed "a complete coverage of over 90 percent of the analyzed struts," according to a press release.
Medtronic wins CE Mark for new drug-eluting stent system
Medtronic Inc. (NYSE:MDT) won CE Mark approval in the European Union for its new drug-eluting coronary stent system.
The Minneapolis-based medical device giant said the device’s new design gives it superior mobility within a patient’s vasculature.
Medtronic said the stent’s new "continuous sinusoid technology" gives the device significantly more deliverability than alternative stents when administered with the its MicroTrac delivery system.
OrbusNeich boasts positive results from Genous stent implantation
A patient implanted with OrbusNeich Medical Inc.’s Genous Bio-engineered R stents showed 100 percent strut and complete neotintimal coverage 26 days after the procedure, the company said.*
The patient, a 62-year-old male, received two 2.5 mm diameter models of the stents after doctors diagnosed an anterior ST-elevation myocardial infarction — a heart attack.
Cordis wins again on appeal in ‘heated’ fight over Cypher stents
Cordis does not use any heat to bond metal to polymer in its Cypher stents and that’s more than cool with a federal appeals court.
A three-judge panel for the U.S. Court of Appeals for the Federal Circuit (CAFC) this week affirmed a lower court decision that found Cypher did not infringe on patents held by Effingham, Ill.-based MarcTec LLC — in effect, siding with the Johnson & Johnson unit because of the way it assembles the drug-eluting stent.
Boston Scientific commences yet another stent trial
Boston Scientific Corp. (NYSE:BSX) has begun enrolling patients for a clinical trial of its "fourth-generation" drug-eluting coronary stent.
The new device, entitled the Synergy, has a bioabsorbable polymer and everolimus drug coating and the same alloy design used in the company’s Promus Element stent.