A Medical Device Daily

An FDA advisory panel on Thursday narrowly approved Atritech's (Plymouth, Minnesota) experimental Watchman device to prevent strokes in patients with irregular heartbeat.

In a 7-5 vote, the FDA panel of outside experts said the device should be approved despite some lingering concerns over some of the data as well as possible complications.

The privately held company is seeking U.S. approval to market the device as a competitor to the widely used blood-thinning drug Coumadin (generically warfarin). It aims to prevent harmful blood clots that can enter the blood stream and cause stroke in patients with atrial fibrillation (AF).

The Watchman left atrial appendage (LAA) device was developed as a mechanical barrier to seal the orifice of the LAA, which is an outpouching of the left atrium. It is known in AF patients that if thrombo-embolic material is found in the left atrium, more than 90% is in the LAA.

The Watchman is a three-part system consisting of a trans-septal access sheath, a delivery catheter, and an implantable nitinol device. The system is designed to facilitate device placement via femoral venous access via the transseptal route into the LAA.

Warfarin is relatively inexpensive but can cause significant bleeding risk and patients must be frequently monitored. Several drugmakers, including Johnson & Johnson (New Brunswick, New Jersey) and Bayer AG (Leverkusen, Germany) also are developing alternatives.

Norman Kato, a panelist and California-based physician, said he voted in favor of Atritech's device "with a lot of trepidation. I still am very, very concerned about the small sample size" of patients in the company's clinical trial, he added.

While Atritech studied 707 patients with atrial fibrillation – 463 were given the Watchman and 244 patients given warfarin – in its PROTECT AF trial, millions more could be eligible for it in the wider marketplace, Kato and others panel members noted.

About 2.2 million Americans have the heart rhythm disorder, according to the American Heart Association (Dallas).

If the FDA were to approve the device, panelists urged the agency to require the company to conduct longer follow-up studies for up to five years and takes steps to ensure that surgeons are properly trained.

Panelists said previously released data from a company-sponsored trial showed the Watchman comparable to warfarin but noted the potential for surgical-related complications and other safety issues.

The FDA will weigh the panel's vote before making its final approval decision.

NIH opens Center for Interventional Oncology

A new Center for Interventional Oncology has been established at the National Institutes of Health Clinical Center. It offers new and expanded opportunities to investigate cancer therapies that use imaging technology to diagnose and treat localized cancers in ways that are precisely targeted and minimally or non-invasive.

The center is a collaboration involving the Clinical Center, NIH's clinical research hospital in Bethesda, Maryland, the National Cancer Institute, and the National Heart, Lung, and Blood Institute.

Bradford Wood, MD, a Clinical Center senior investigator, is chief of the new center. "The Center for Interventional Oncology will help foster advances in an emerging field for minimally invasive, image-guided methods for treating localized cancers," he said. "It will also help bridge the gap between emerging technology and the everyday practice of medicine. Advanced imaging methods have ushered in an era of early detection of cancers that are frequently localized to a single organ. Today, oncology treatments typically use systemic therapies such as chemotherapy, surgery, and radiation, which are well-suited for wide-spread disease, but may also cause widespread side effects."

The new center is intended to provide a forum for and encourage collaborations among research and patient-care experts in medical, surgical, and radiation oncology and interventional radiology, noted John Gallin, MD, Clinical Center director. "The Clinical Center provides an exceptional environment for this type of collaborative research and patient care."

The new center's goal is localized treatment and drug delivery by use of advanced imaging technologies located at the Clinical Center, including cutting-edge magnetic resonance imaging, positron emission tomography, and computed tomography – combined with the capability to use all three technologies simultaneously to navigate a therapeutic device through the body.

The localized therapies use a thin needle or sound waves to ablate tumors and to enhance drug delivery. Energy sources include high-intensity focused ultrasound, freezing, microwaves, and radio frequency, Wood said. Researchers will also expand investigations into electroporation – the use of electricity to make cells more open to targeted drug delivery. Image-guided drug delivery will be developed, which will allow combining use of nanoparticles, ablative devices, and advanced imaging and navigation.

David Bluemke, MD, PhD, director of Clinical Center radiology and imaging sciences, will head the Center for Interventional Oncology steering committee that comprises two NCI appointees and one each from NHLBI and the Clinical Center.

FDA allows court ruling on Plan B OTC sales

On March 23, a federal court issued an order directing the FDA, within 30 days, to permit the Plan B drug sponsor to make Plan B available to women 17 and older without a prescription. The agency said it would not appeal the decision.

In accordance with the court's order, and consistent with the scientific findings made in 2005 by the Center for Drug Evaluation and Research, FDA said it notified the manufacturer of Plan B, Duramed Research (Bala Cynwyd, Pennsylvania), informing the company that it may, upon submission and approval of an appropriate application, market Plan B without a prescription to women 17 and older.