AtriCure gets FDA nod to try hybrid atrial fibrillation procedure
Updated 8:10 p.m., May 10, 2010.
Atricure Inc. (NASDAQ: ATRC), the maker of cardiac surgical ablation systems, has received a conditional nod from the Food and Drug Administration (FDA) to evaluate the safety and efficacy of a hybrid procedure to treat patients with persistent forms of atrial fibrillation.
The hybrid procedure “represents a key growth platform” for AtriCure and other companies that seek to serve the atrial fibrillation market, said David J. Drachman, the company’s president and chief executive officer, in its first quarter earnings release. There is a significant hurdle for potential market players: the FDA has yet to approve cardiac ablation as a treatment for atrial fibrillation.
Atricure will try a “dual epicardial/endocardial procedure” (DEEP) on 30 patients at up to five U.S. medical the company said. Enrollment is expected to begin in the second half of the year.
The hybrid procedure combines surgical and catheter ablation with endovascular mapping, using the skills of cardiac surgeons and electrophysiologists to treat patients with persistent atrial fibrillation (AF), which is an abnormally fast heart rhythm that can lead to heart attack or stroke.
Now, surgical and catheter ablation techniques often are used separately. Endovascular mapping during procedures — using imaging technology to “see” the effects of ablation procedures in real-time — is just emerging. The trial will use AtriCure’s minimally invasive surgical ablation technology platform and the Biosense Webster THERMOCOOL catheter ablation technology.
The nation’s top heart centers are beginning to build hybrid operating rooms to enable cardiac surgeons and electrophysiologists to do their parts in ablation procedures at the same time. Meanwhile, the West Chester, Ohio, medical device maker is using its Synergy Bipolar System to treat atrial fibrillation in clinical trials that are moving the heart centers toward using ablation to treat AF.
AtriCure said late Monday afternoon it narrowed its first-quarter loss to $2 million, or 13 cents a diluted share, from $8 million, or 56 cents a diluted share, in the year-ago quarter. Most of that difference came from a $6.8 million charge to lower the value of “good will” in the 2008 first quarter.
Revenue grew 2 percent to $14 million — the company’s best performance in six quarters — from $13.7 million a year ago. The rise in revenue was modest, but it came from a 27 percent increase in international revenues.
Since getting market clearance in the United States to sell Cryo1, a disposable medical device that uses extreme cold to ablate the heart, the company has captured 20 percent of the surgical cryothermia products market, Drachman told securities analysts during a Monday conference call.
AtriCure had expected to boost revenue in the first half of 2010 by launching its AtriClip product in the United States. Invented by Dr. Delos “Toby” Cosgrove, CEO of the Cleveland Clinic, and Dr. A. Marc Gillinov, a cardiac surgeon there, AtriClip is used by heart surgeons during cardiac ablation procedures to reduce patients’ risk of stroke.
Though it was cleared for European sales in mid-2009, AtriClip helped the Cincinnati-area company to a 28 percent increase in international sales that year.
However, the U.S. AtriClip introduction likely will be delayed until the first half of next year, Drachman said. A newly assigned FDA reviewer has questioned animal tests done with the clip and reported in 2007. AtriCure still sees large U.S. market potential for the clip — “approximately 185,000 patients representing a market opportunity for our AtriClip system of roughly $150 million per year” – Drachman said.
After cutting sales staff last year while dealing with challenges like a Department of Justice investigation and related whistle-blower lawsuit that have since been resolved, AtriCure now is adding U.S. and European sales people.
“In order to capitalize on the increasing strength of our product portfolio, we have made strategic investments to expand our sales and marketing infrastructure, which we believe positions us for an acceleration of revenue growth and market share gains,” Drachman said.