Startup wins PMA approval for direct-visualization, endoscopic ablation for afib

Balloon catheter of the HeartLight system--Courtesy of CardioFocus

CardioFocus has nabbed an approval from the FDA for its HeartLight Endoscopic Ablation System to treat paroxysmal atrial fibrillation. There are a handful of catheter ablation tools already approved in that indication, such as Johnson & Johnson's ($JNJ) Thermocool and St. Jude Medical's ($STJ) TactiCath, but the Marlborough, MA-based startup said its device is the first to allow electrophysiologists to use direct visual guidance while in the pulmonary veins, while others rely upon x-ray or mapping instead.

Other electrophysiology players Boston Scientific ($BSX) and Abbott ($ABT) have made recent moves on catheter-based ablation treatment of afib; the former with an ablation catheter FDA approval to treat a related condition, atrial flutter, and the latter with the acquisition of startup Kalila Medical to gain a sheath for its own ablation device to enable atrial fibrillation treatment.

For its part, CardioFocus has raised more than $62 million in equity and debt since 2008 from investors including H.I.G. Ventures, KBL Ventures, Oxford Biosciences Partners, SV Life Sciences, Aurora Funds, Accuitive Medical Ventures, Kestrel Venture Management and Fletcher Spaght Ventures. The most recent financing of $32 million in equity that was raised in January 2015.

Balloon catheter sheath of the HeartLight system--Courtesy of CardioFocus

The startup is prepping to launch HeartLight in the U.S. It's had a CE mark in Europe since 2009 and the system has already been used in more than 3,400 patients. The FDA-approved indication is specifically for treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation.

Across several EU studies, the company found rates of up to 80% of freedom from atrial fibrillation recurrence after one year or more of one ablation procedure. The U.S. clinical trial tested HeartLight versus Biosense Webster's Thermocool. It found that the majority of patients remained free of paroxysmal AF at 12 months--and the study found that it was non-inferior to Thermocool.

The HeartLight System uses a balloon catheter to navigate pulmonary veins and works to deliver laser energy under direct endoscopic visualization. Atrial fibrillation is the most common cardiac arrhythmia.

"Based on our experience in the CardioFocus pivotal study and the successful results from the EU, I am confident that this new laser balloon catheter will offer our patients an outstanding treatment option for atrial fibrillation," said Dr. Frank Cuoco, Associate Professor of Medicine at the Division of Cardiology at the Medical University of South Carolina in Charleston, SC. He was one of the highest enrollers of patients in the HeartLight study.

He added, "The flexibility of the compliant balloon, which is intuitive to use under direct visual guidance, is one of its primary appeals. I found the learning curve to be very short."

- here is the release