Cordis Corp. announced it has completed the acquisition of Flexible Stenting Solutions Inc., whose technology provides Cordis with the opportunity to evolve the S.M.A.R.T. stent platform to address unmet needs in the treatment of peripheral artery disease (PAD).

Svelte Medical Systems announced treatment of the first patient in the DIRECT II (Direct Implantation of Rapamycin-Eluting stents with bioabsorbable drug Carrier Technology) study at Middelheim Hospital in Antwerp, Belgium. DIRECT II is a prospective, randomized, multi-center clinical study comparing the safety and efficacy of the Svelte drug-eluting coronary stent Integrated Delivery System (IDS) to Medtronic’s Resolute Integrity drug-eluting stent. The study builds on the positive 6-month results of the DIRECT I first-in-man study which evaluated the Svelte drug-eluting coronary stent IDS in 30 patients in New Zealand. In DIRECT I, the Svelte drug-eluting coronary stent IDS met all study endpoints and demonstrated in-stent neointimal volume obstruction of 2.7 percent as assessed by intravascular ultrasound (IVUS), which is one-third to one-half the volumetric obstruction observed in market-leading drug-eluting stent first-in-man studies.

TherOx Inc. announced the initiation of its multicenter Investigational Device Exemption (IDE) pilot study of a second generation system that delivers supersaturated oxygen (SSO2) therapy for reduction of infarct size after an AMI. SSO2 therapy is intended to provide interventional cardiologists with the first treatment option beyond percutaneous coronary intervention (PCI) to salvage heart muscle in heart attack patients.

Northwest Community Healthcare (NCH) is unveiling new imaging and lab results functionality for its mobile app, MyNCH, which allows NCH Medical Group patients to view their lab and imaging results with just the tap of a finger on their smartphone.

Edwards Sapien, PARTNER, 3 year followup

The three-year results of a pivotal clinical study comparing the Edwards Sapien transcatheter heart valve and open-heart surgery demonstrated comparable outcomes. These new data from The PARTNER Trial were presented today as a late-breaking clinical trial at the American College of Cardiology's (ACC) 62nd Annual Scientific Session in San Francisco.

Spacelabs Healthcare has released the latest version of their cardiology information management system — Sentinel v.9 — with a new seamlessly integrated ABP module.

 

Terumo Interventional Systems expanded its family of Heartrail III Coronary Guiding Catheters to include a smaller profile 5 French Ikari shape, specifically designed to provide backup support and access to target coronary lesions during transradial catheterizations.  The smaller 5 French Heartrail is designed to help physicians achieve access to the coronary arteries using a smaller-diameter catheter platform, and proprietary Ikari tip shapes, while providing the backup support and body of a traditionally larger French size catheter.

Alere Inc. announced the results of research presented at the American College of Cardiology’s 62nd Annual Scientific Session, which showed that a simple screening and management program can be effective in preventing heart failure for at-risk patients.

ekos, pulmonary embolism, clot busting

Results of the ULTIMA trial using endovascular therapy to treat submassive pulmonary embolism (PE) were presented at the American College of Cardiology 2013 meeting, The trial is the first randomized controlled trial comparing the use of an endovascular approach along with anticoagulation vs. anticoagulation therapy alone, the current standard of care.
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