OrbusNeich announced the presentation of the one-year clinical outcomes from the 1,000-patient REMEDEE Registry at the 2015 Transcatheter Cardiovascular Therapeutics (TCT) meeting, Oct. 11-15 in San Francisco. Data was presented by Robbert de Winter, M.D., Ph.D., of the Academic Medical Center, Amsterdam and principal investigator of the study.

Medinol announced in September the completion of enrollment in its BIONICS trial to evaluate the safety and effectiveness of a new coronary stent system, the first-ever elastomeric drug eluting stent (eDES).

CardioKinetix Inc. announced that it has received regulatory approval for the Parachute system in South Korea by the Korean Ministry of Food and Drug Safety (MFDS).

Results of the TUXEDO trial, designed to compare two types of stents in diabetic patients, found paclitaxel-eluting stents failed to meet non-inferiority criterion compared to everolimus-eluting stents for the primary endpoint of target-vessel failure at one year.

A randomized trial found that ranolazine did not reduce the composite rate of ischemia-driven revascularization or hospitalization in patients with a history of chronic angina who had residual unrevascularized coronary artery disease after percutaneous coronary intervention (PCI).

Medtronic plc released the first CoreValve transcatheter aortic valve replacement (TAVR) system outcomes data using CoreValve data from The Society of Thoracic Surgeons and American College of Cardiology (STS/ACC) Transcatheter Valve Therapy (TVT) Registry. The data show that everyday clinical experience from 6,160 CoreValve patients treated by a wide variety of heart team implanters replicates the excellent outcomes achieved in robust clinical trials. The primary outcomes of all-cause mortality and stroke in the STS/ACC TVT Registry were numerically similar to the findings in the CoreValve U.S. Pivotal Trial, which demonstrated statistical superiority to surgical aortic valve replacement in high-risk patients.

Results from the LEADERS FREE trial found that a polymer-free drug-coated stent (DCS) was superior to a bare-metal stent (BMS) in high-bleeding-risk patients treated with one month of dual antiplatelet therapy (DAPT). It was the first randomized clinical trial dedicated to this particular patient population.


Results from the ISAR-DESIRE 4 trial indicate that use of a scoring balloon plus a paclitaxel-coated balloon (PCB) was angiographically superior to a paclitaxel-coated balloon alone for the treatment of restenosis within limus-eluting stents.


Direct Flow Medical Inc. announced one-year outcomes from the DISCOVER post-market study that demonstrate excellent real-world results for the Direct Flow Medical Transcatheter Aortic Valve System. The data were presented last week at the Transcatheter Cardiovascular Therapeutics (TCT) annual meeting by Federico De Marco, M.D., from the Policlinico San Donato in Milan, Italy.

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