St. Jude Medical (NYSE:STJ) said today that the FDA granted pre-market approval for its next-generation Ilumien Optis device, which combines a pair of technologies to help guide physicians during stenting procedures.
Stents
Bard’s stent recall gets FDA highest-risk label
Covidien’s got a ‘new approach’ to peripheral arterial disease
Boston Scientific launches Innova DES study, updates on OffRoad re-entry catheters
Stent pioneer Saffran asks Supremes to hear appeal in $600M patent case against J&J’s Cordis
Stent pioneer Dr. Bruce Saffran asked the U.S. Supreme Court to hear an appeal of a lower court’s decision to overturn his $593 million win in a patent infringement lawsuit against Johnson & Johnson‘s (NYSE:JNJ) Cordis stent-making arm.
Medtronic lands extended FDA approval for Complete SE vascular stent
Bypass beats stenting for diabetics | MassDevice.com On Call
MASSDEVICE ON CALL — The risk of death was reduced by a third in patients with diabetes who underwent coronary artery bypass graft surgery, compared with percutaneous coronary intervention with stents, according to new study results.
Researchers examined data from 4 clinical trials comparing CABG with PCI using bare-metal stents in diabetics with multi-vessel heart disease and another 4 trials that compared CABG with drug-eluting stent PCIs.
Gore launches carotid stent trial
W.L. Gore & Associates said it’s launched the Scaffold clinical trial of a stent designed to treat carotid artery stenosis.
The 1st patient in the trial was implanted with the device by Dr. Claudio Schönholz of the Medical University of South Carolina in Charleston, according to a press release.
Boston Scientific closes enrollment in Synergy stent trial
Boston Scientific (NYSE:BSX) said it finished enrolling 1,684 patients in a clinical trial of its next-generation Synergy drug-eluting stent, aiming to use the data to back regulatory nods in the U.S. and Canada.
Cook Medical lands extra Medicare coverage for Zilver PTX stent
Cook Medical touted new Medicare reimbursement coverage for its Zilver PTX drug-eluting stent, which now qualifies for Medicare’s new-technology add-on payments, according to a company statement. The additional payments are available only for in-patient procedures, not affecting physician or hospital coverage for out-patient procedures or ambulatory surgery center reimbursements.