Medtronic plc today announced the first patient enrollment in the GOLD AF Registry, a first-of-its-kind, prospective, observational clinical study of its Phased Radiofrequency (RF) Ablation technology for treating patients with symptomatic atrial fibrillation (AF). The multicenter registry will provide real-world insights into the procedural use and treatment outcomes of the Pulmonary Vein Ablation Catheter® (PVAC) GOLD, multi-electrode ablation catheter and other catheters that comprise Medtronic's Phased RF technology.

Dr. Daniel Melby, an investigator at the Minneapolis Heart Institute Foundation (MHIF), performed the first atrial fibrillation ablation in the U.S. using Biosense Webster’s new THERMOCOOL SMARTTOUCH SF contact force sensing catheter as part of an FDA regulated safety trial (SMART-SF). Biosense Webster is part of the Johnson & Johnson family of companies. “The SMARTTOUCH SF catheter is an important evolution in RF ablation technology,” said Dr. Melby. “Contact force sensing combined with the more efficient irrigation design of this catheter may allow for a more effective ablation pattern while potentially reducing risk of thrombus formation and improving outcomes.” 

A team of investigators at Children’s Hospital Los Angeles and the University of Southern California have developed the first fully implantable micropacemaker designed for use in a fetus with complete heart block. The team has done preclinical testing and optimization as reported in a recent issue of the journal Heart Rhythm. The micropacemaker has been designated a Humanitarian Use Device by the US Food & Drug Administration (FDA). The investigators anticipate the first human use of the device in the near future.

It's been nearly a decade since Gheorghe Sandru received the heart implant that changed his life.

Full results from a Phase 3 study examining Portola Pharmaceutical's developmental compound andexanet alfa found it rapidly and significantly reversed the blood thinning (anticoagulant) effects of XARELTO (rivaroxaban). These results, from the first part of the ANNEXA-R (Andexanet Alfa a Novel Antidote to the Anticoagulant Effects of fXa Inhibitors – Rivaroxaban) study, will be presented at the 64th Annual Scientific Session of the American College of Cardiology (ACC) on March 16, 2015. Additional findings to be presented at the meeting include new 24-month results from an ongoing, five-year, observational study of people with non-valvular atrial fibrillation taking XARELTO, which showed the rates and patterns of major bleeding in routine clinical practice were generally consistent with those observed in Phase 3 clinical trials used to approve the medicine for this indication.

Newly published research led by the Minneapolis Heart Institute Foundation (MHIF) and Tufts Medical Center in Boston shows that implantable defibrillators (ICDs), along with other modern treatments, have reduced mortality rates and are helping patients with hypertrophic cardiomyopathy (HCM) live longer, including normal life expectancy. This research “changes our perceptions of HCM from a grim, unrelenting, and largely untreatable condition to a contemporary disease with effective treatment options and a low rate of death,” states Dr. Barry Maron, lead researcher and Director of the HCM Center at MHIF. Dr. Maron will present the results of the study at the American College of Cardiology (ACC) conference in San Diego, CA on March 14.

Johnson & Johnson will give outside researchers access to clinical data on diagnostics and medical devices through Yale University, but the largesse applies only to products approved in 2014 or later. That makes the ThermoCool SmartTouch catheter available for scrutiny, the New York Times reports. 

Medtronic  today announced the U.S. Food and Drug Administration (FDA) approval and commercial launch of two additional Attain Performa left ventricular (LV) quadripolar leads, which can be paired with the Medtronic Viva Quad XT and Viva Quad S cardiac resynchronization therapy defibrillators (CRT-D) to treat patients with heart failure. The newest additions to the Attain Performa lead portfolio, the S-shape and Straight leads, are designed to accommodate patients' varying vessel sizes and curvatures to enhance successful lead placement. Quadripolar leads (leads with four electrodes) help physicians optimize cardiac resynchronization therapy, which uses an implantable device to improve the pumping efficiency of the heart.