TAVI registries showing greater success with experience, upgrades
Structural Heart
Boston Scientific lands updated CE Mark for Promus Element, Promus Element Plus stents
Medical device industry titan Boston Scientific (NYSE:BSX) won expanded CE Mark approval in the European Union to update the directions for use on its Promus Element and Promus Element Plus coronary stents.
TCT 2012: Drug-eluting and semi-resorbable stents hold their own
Stent makers came out in force for the Transcatheter Cardiovascular Therapeutics meeting in Miami this week, touting results of clinical studies of next-generation drug-eluting stents and new designs with bioresorbable polymers.
Stent wars at TCT 2012: Drug-eluting stents maintain lead over bare-metal
With new and next-generation stents gaining ground over their forebears, the stent wars don’t look to be letting up anytime soon.
The battle continued at the Transcatheter Cardiovascular Therapeutics meeting this week, where pooled results from a pair of studies further affirmed that next-generation drug-eluting stents demonstrate better safety and efficiency at 1 year compared to bare-metal stents.
Researchers combined data from the Examination and Comfortable AMI studies, which comprised a total of more than 2,600 patients, to look for larger trends in the DES vs. BMS battle.
TCT 2012: New trials and positive results for cardiac implants
Stentys lands FDA nod to launch 1st U.S. trial with novel Self-Apposing stent
Stent maker Stentys SA (EPA:STNT) won FDA investigational device exemption to launch its 1st U.S. clinical trial of its Self-Apposing stent that it hopes to use in support of a premarketing approval bid.
The announcement was made as the company, in a separate release, unveiled interim results of its Apposition III trial during the Transcatheter Cardiovascular Therapeutics conference in Miami this week.
TCT2012: Medtronic’s CoreValve system shows high survival rate
Minneapolis health giant Medtronic (NYSE:MDT) unveiled new findings from its CoreValve Advance study, showing a 1-year survival rate of 82.1% and improved health-rated quality of life at 1 and 6 months.
Medtronic’s CoreValve device is a self-expanding heart valve prosthetic that can be delivered via catheter rather than through surgery.
FDA approves Svelte’s stent delivery pivotal trial
New Providence, N.J.-based Svelte Medical Systems won conditional approval from the FDA to launch a pivotal human trial of its Svelte coronary stent Integrated Delivery System, designed to streamline stenting and thereby reduce procedure time and cost.
Svelte won approval to enroll around 370 patients at up to 30 U.S. sites to evaluate the safety and effectiveness of its IDS, which combines a wire, balloon and stent into an all-in-one low-profile and highly flexible system.
Gore lands FDA approval to add next-gen septal occluder to Reduce study
W.L. Gore & Associates today announced that it had won FDA approval to adds its next-generation GORE Septal Occluder to its Reduce clinical study, which is already evaluating its older Helex septal occluder in prevention of recurrent stroke in patients with patent foramen ovale, a hole between the upper chambers of the heart.
AngioScore initiates 1st-in-human study of CardioSculpt balloon
Angioplasty catheter manufacturer AngioScore successfully initiated a 1st-in-human trial evaluating its CardioSculpt valvuloplasty scoring balloon in treatment of critical aortic valve stenosis.
The study will enroll 30 patients with symptomatic critical aortic valve stenosis who are not eligible for transcatheter treatment or surgical valve replacement.
Edwards wins extended Sapien TAVI approval, sinks on disappointing Q3
Edwards Lifesciences (NYSE:EW) won FDA approval to market its Sapien transcatheter aortic valve implantation system to lower-risk patients, despite concerns about limited patient data on the long-term side effects of the device.