Biosense Webster Inc. reported U.S. FDA approval of its Thermocool Smarttouch SF ablation catheter for the treatment of patients with persistent atrial fibrillation (persistent AF). This follows results of the prospective, multicenter Precept study, which showed the catheter to be safe and effective for 80% of patients over 15 months of ablation therapy with clinically meaningful improvement in quality of life.
Fitbit Inc. and Apple Inc. picked up the pace in their race to put health monitoring apps on wrists everywhere with Fitbit gaining 510(k) clearance from the U.S. FDA for its new ECG app for the Fitbit Sense and Apple revealing the blood oxygen sensor built into its Series 6 watch this week. The new apps join a growing array of technological advances that permit wearable devices to track and record a range of health metrics.
Advanced diagnostics startup Coremap Inc., which is developing a technology capable of identifying the drivers of atrial fibrillation (AF), scooped up $10.5 million in a series A financing led by Qure Ventures. The funds will be used to accelerate product development and future regulatory submissions. Founded in 2016, the Burlington, Vt.-based company has raised nearly $12 million to date.
The U.S. FDA has been easing gently down the road of real-world evidence (RWE) in regulatory decision-making, and the case of the Watchman left atrial appendage device is instructive in this regard. Robert Shipley, of Boston Scientific Corp. (BSX), said on webinar hosted by the Advanced Medical Technology Association that the FDA changed gears and agreed to a registry for a post-approval study for the first generation Watchman, but added that the use of registry data and other RWE for approval of a next-generation device is as yet more aspirational than practicable.
New medical instruments with integrated soft electronics could improve diagnosis and treatment of cardiac conditions. The surgical tools use soft materials that conform to the body’s tissue and permit a single catheter to combine diagnostic and therapeutic functions while providing real-time feedback and electrophysiological information.
Cryoablation for paroxysmal atrial fibrillation (PAF) is not the standard of care, but a recent study may change at least some clinicians’ thinking on that score.
Startup Conformal Medical Inc. has reeled in $85 million in a series C round to support a U.S. pivotal trial of its CLAAS technology, a device designed to seal off the heart’s left atrial appendage (LAA) to reduce the risk of stroke in patients with atrial fibrillation. The financing included participation from new investors Fidelity Management & Research Company LLC and an undisclosed strategic investor.
Makers of devices for ablation for atrial fibrillation (AF) have struggled at times to overcome clinician skepticism, but a new report in a respected medical journal might persuade some of those cardiologists. A study of nearly 28,000 AF patients in South Korea demonstrated that device therapy yielded lower rates of death and admission for heart failure compared to medical therapy, suggesting that ablation is a valid alternative to medical therapy, at least for patients in Asia.
Boston Scientific Corp. reported the U.S. launch of its Directsense technology, a tool to aid electrophysiologists in measuring tissue response to radiofrequency (RF) waves during cardiac ablation procedures. Approved by the FDA in April, the technology is available on the company’s Rhythmia HDx mapping system.
Wearables giant Fitbit Inc. has kicked off its first large-scale, virtual study to evaluate how well its wrist-worn technology can spot episodes of irregular heart rhythm that might indicate atrial fibrillation (AF). The study, part of a broader plan to equip Fitbit devices with new tools to speed the detection of a range of conditions, is open to people in the U.S. ages 22 and older who own a Fitbit that tracks heart rate.
