Claret embolic protection, TAVR, cerebral protection
Claret embolic protection, TAVR, cerebral protection

October 14, 2015 — Claret Medical, an innovator in cardiovascular cerebral protection, Data presented this week at Transcatheter Cardiovascular Therapeutics (TCT) 2015 showed the first definitive cognitive benefit from use of a cardiovascular cerebral protection system during transcatheter aortic valve replacement (TAVR) procedures. 
ABSORB III trial, TCT 2015, bioresorbable vascular scaffold, BVS

Results from a clinical trial showed that an everolimus-eluting bioresorbable vascular scaffold was non-inferior after one year compared to a current generation metallic drug-eluting stent (DES) in patients with coronary artery disease. Target lesion failure (TLF) was the primary endpoint for the study.

Edwards Lifesciences Corp. announced that details on the 13 first-in-human compassionate use cases with its Forma transcatheter tricuspid repair system were presented at the 27th Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation.  The results of the first seven cases were also published online this week in the Journal of the American College of Cardiology.

Two new advances in stent technology announced in recent days further reinforce the effectiveness of the next-generation bioabsorbable stents. Both new stents are designed to help reduce the risk of long-term complications for patients receiving a stent and will give interventional cardiologists more options in the care of cardiovascular patients.

PARTNER II Trial, TCT 2015, Edwards Lifesciences, Sapien 3 valve, one-year results

One-year patient outcomes from the PARTNER II trial showed the low rate of 30-day complications with balloon-expandable transcatheter aortic valve replacement (TAVR) in high-risk and inoperable patients with aortic stenosis persisted with follow-up to one year.

October 15, 2015 — U.S. Food and Drug Administration (FDA) has cleared Edwards Lifesciences Sapien XT transcatheter aortic valve for aortic valve-in-valve (VIV) procedures. It became the second transcatheter valve to receive the VIV indication. The Medtronic CoreValve received the indication this past March.

Biotronik has announced results from the BIOSOLVE-II trial, investigating the safety and clinical performance of the world’s first clinically proven magnesium-based bioresorbable scaffold, at the Transcatheter Cardiovascular Therapeutics (TCT) 2015. The bioresorbable scaffold met its primary angiographic endpoint and demonstrated an outstanding safety profile. The announcement of clinical data from BIOSOLVE-II will be accompanied by publication in The Lancet.

C. R. Bard Inc. announced the presentation of the 12-month results from the Lutonix Global Real-World Registry at the Transcatheter Cardiovascular Therapeutics (TCT) 2015 meeting. These results come just months after publication in the New England Journal of Medicine of the one-year data from the Lutonix 035 drug coated balloon (DCB) catheter pivotal, randomized LEVANT 2 trial.

Tryton Medical Inc. announced results from the pivotal Tryton Confirmatory Study confirming the acceptable acute safety profile of the Tryton Side Branch Stent for the treatment of coronary bifurcation lesions in vessels appropriate for a ≥2.5mm stent. Results were presented as part of the Featured Clinical Research session at Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation (CRF) being held in San Francisco, California.

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