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.

ISAR-DESIRE 4 trial, TCT 2015, drug-coated balloon, DCB, scoring balloon, SCB, drug-eluting stent restenosis

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.

PulsePoint Respond app, new CPR guidelines, sudden cardiac arrest, social media
Physio-Control, PulsePoint Respond app, new CPR guidelines, social media

For the first time, cardiopulmonary resuscitation (CPR) guidelines issued by the American Heart Association (AHA) recommend communities consider using social media and mobile app technology to alert CPR responders when someone nearby suffers sudden cardiac arrest. The new guidelines cite studies that show emerging mobile technologies can result in a “higher rate of bystander-initiated CPR.”

Bracco Diagnostics Inc. announced that Lumason was approved by the Centers for Medicare and Medicaid Services (CMS) for pass-through status under the Hospital Outpatient Prospective Payment System (HOPPS). Lumason is an ultrasound contrast agent indicated for use in adults with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border.

thrombus aspiration, STEMI patients, TCT 2015, TOTAL study

A pair of studies presented at the 27th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium showed no late benefit of thrombus aspiration during percutaneous coronary intervention (PCI) in patients with ST-segment elevation myocardial infarction (STEMI).
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