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.

On Oct. 7, 2015, Cook Medical initiated a voluntary recall for select sizes of Beacon Tip Angiographic Catheters. This recall includes all lots of these select sizes of the Beacon Tip Angiographic Catheters. This recall is an expansion of the voluntary lot-specific recall issued on July 2, 2015.

AtriCure Inc. announced it has entered into a definitive merger agreement under which AtriCure has agreed to acquire nContact Inc., a privately held developer of innovative cardiac ablation solutions.

Boston Scientific Corp. announced it has closed on an additional round of financing with MValve Technologies Ltd., developer of a percutaneous mitral valve replacement system designed to work with the Boston Scientific Lotus Valve. Boston Scientific has provided the company with funding since 2012 and has an exclusive option to acquire MValve.

Kopp Development Inc. has released a new entryway system for magnetic resonance imaging (MRI) rooms — FerrAlert Halo II Plus. This detection system dramatically reduces alarm fatigue by not alarming on the MRI door and ferromagnetic objects exiting the MRI room. Alarm fatigue reduction is a top priority for ECRI and The Joint Commission.

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