Someday, in the not-so-distant future, EnteroMedics Inc. officials might look back at late 2009 and laugh. Or cry.That ultimately depends on whether the Food and Drug Administration ultimately approves or rejects the company’s groundbreaking Maestro device. Approval means enormous financial success, the only implantable neurostimulation device in the United States designed to treat obesity. Rejection [...]

Patients will measure their vital signs such as blood pressure, pulse and weight, and respond to questions related to their diseases on a daily basis. A clinical care team will review the data, and will be able to use videoconferencing to further evaluate the patients.

EnteroMedics and Leptos are both developing a device that uses electricity to treat obesity. But that’s where the similarities end, EnteroMedics CEO Mark Knudson told me in a quick phone call.

Leptos had raised at least $10 million from big venture capital firms like Thomas, McNerney Partners in Minneapolis, Technology Partners in Palo Alto, Calif. and Spray Ventures in Newton, Mass. Like EnteroMedics Inc. in Roseville, the company was developing a device that used electricity to manipulate signals between the brain and stomach.

After discussions with the U.S. Food and Drug Administration, EnteroMedics will apply for approval to conduct another human trial to supplement results from an earlier study, which showed the company’s Maestro’s device did not perform any better than the control group.

Last November, Nasdaq threatened to delist EnteroMedics because its stock failed to trade above $1.00 for ten consecutive days. The company has until May 12, 2010 to comply with the rule or face expulsion- again.

EnteroMedics is dangling precariously off a cliff. Last fall, initial results from its Empower clinical study failed to meet the company’s goals.

The medical device industry, long the backbone of Minnesota’s high tech economy, faces perhaps its most challenging environment in decades. From regulatory headaches and health care reform to a dearth of venture capital, medical device stakeholders face a swirling mix of uncertainty and anxiety.