As start-up companies go, Atritech Inc. has been a kind of golden child in Twin Cities medical-technology circles.
The Plymouth-based firm has raised $90 million in venture capital so far and attracted an experienced CEO, Jim Bullock, to its fold. Its signature device, called Watchman, treats a heart condition called atrial fibrillation, which afflicts some 3.3 million people nationwide and is a leading cause of stroke.
After a decade of development, Atritech appeared before a Food and Drug Administration (FDA) panel last spring, and won a recommendation for approval to market Watchman.
Since the FDA usually follows its own panel's recommendations, full approval was expected in short order. Company officials excitedly prepared to launch their new product.
But for many months, no news came out of Atritech. Or the FDA.
Then last month, the company confirmed in a news release that it had "obtained clarity" from the FDA on Watchman's path toward regulatory approval. That "clarity" involves conducting a confirmatory study to further substantiate the safety and effectiveness of the device. But what that study will involve -- the number of patients and its overall design -- is still unknown.
Bullock was circumspect last week when asked about the company's final and seemingly most-difficult chapter before a commercial launch. "The FDA said 'You need to collect more data,' and they reserve the right to do that," he said.
The challenges facing Atritech in dealing with the FDA are certainly not unique in the medical-device industry. The agency has been under fire by critics who claim the approval process is too lenient. On the flip side, med-tech entrepreneurs complain that the agency has grown too conservative in approving medical devices, making it cost-prohibitive to develop innovative products. Some fledgling companies, such as Eden Prairie-based Disc Dynamics, simply run out of money and fold as a result.
The agency itself is undergoing vast change under the Obama administration, with a new commissioner, Dr. Margaret Hamburg, and head of the medical device division, Jeffrey Shuren.
"The FDA is getting so academic in their approach, the data requirements of companies continues to escalate," said Mark DuVal, a Minneapolis attorney who specializes in FDA issues. "I don't know if there's an end in sight. It's very concerning."
The FDA panel vote last year was 7-5 in favor of approval. DuVal speculates the relatively close vote spurred the agency's request for more data on the device. "The rule of thumb is that a 7-5 split is close enough that they'll sometimes want additional data," he said. "It's kind of unwritten agency policy."
During the hearing, several panel members expressed concern about the study's design, and they called for follow-up to further prove the Watchman device is safe.
An FDA spokeswoman referred all questions about Atritech to the company.
Approved in Europe
Atritech's pivotal clinical trial evaluated its Watchman device against the drug warfarin (also known as Coumadin), the current standard of care for patients with atrial fibrillation. The study enrolled about 800 patients -- large by medical-device standards -- with an average follow-up of two years.
The device looks like a tiny parachute and is inserted at the opening of the left atrial appendage, a thumb-like protrusion of the heart where blood clots often form. Using a technique similar to angioplasty, a catheter is inserted through a vein in the groin and snaked to the heart, where the device is deployed. The device is designed to prevent blood clots from getting into the bloodstream and causing a stroke.
According to a presentation at the recent American College of Cardiology meeting, follow-up data from the clinical trial indicated a 31 percent risk reduction in stroke, cardiovascular death and blood clots in patients treated with the device. Comparable results were published in the August 2009 edition of the British medical journal, Lancet.
Meanwhile, the device is approved for use in Europe, where the company has a sales force and distribution network in place. Demand for the implants, Bullock said, is strong.
Janet Moore • 612-673-7752
