Medtronic today announced Japanese regulatory approval and launch of the Evera MRI(TM) SureScan® implantable cardioverter-defibrillator (ICD) System for magnetic resonance imaging (MRI) scans positioned on any region of the body. Reimbursement also was approved by Japan's Ministry of Health, Labor and Welfare (MHLW). The Medtronic Evera MRI ICD is currently limited to investigational use in the United States.

The device maker Biotronik agreed to pay $4.9 million to settle a whistleblower lawsuit that alleged the company’s cardiac rhythm business committed fraud by “improperly inducing” cardiologists and electrophysiologists to implant its devices in patients.

At five years, the Zilver PTX stent proved to be a durable treatment for peripheral artery disease with sustained benefit, results presented Nov. 4 at the 2014 Vascular Interventional Advances (VIVA) meeting showed.

For multivessel disease, “if it isn’t broken, don’t fix it” may also apply to PCI. A retrospective look at a London cohort points to treating only the culprit vessel of STEMI as the best method for improved patient outcomes through one year.

Shockwaves appear to have early success in breaking up calcified lesions safely. In research presented Nov. 5 at the 2014 Vascular Interventional Advances (VIVA) meeting in Las Vegas, a lithotripsy-with-balloon technique used on peripheral artery lesions resulted in all patients achieving less than 50 percent stenosis. 

Covidien announced 12-month results of the DEFINITIVE AR study, the first randomized study designed to identify the clinical benefits of plaque removal using directional atherectomy followed by drug coated balloon. The results were presented by Professor Thomas Zeller of the Universitaets-Herzzentrum, Bad Krozingen, Germany at the Vascular Interventional Advances (VIVA) 2014 conference in Las Vegas, Nev.

Risks for silent cerebral infarctions were two times greater in patients with atrial fibrillation, according to a meta-analysis published Nov. 4 in Annals of Internal Medicine. Researchers noted that this increased risk remained regardless of whether the atrial fibrillation was paroxysmal or persistent.

A comparison of randomized clinical trials that assessed dual-antiplatelet therapy (DAPT) durations showed such trials should include treatment periods and case fatality rates to better understand the risks and benefits. Using this approach, researchers saw hints of a mortality advantage with 12-month DAPT.