Balloon catheter shows promise for sinus woes

Releases mucus less invasively

By Thomas Lee MINNEAPOLIS STAR TRIBUNE | Tuesday, July 22, 2008

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MINNEAPOLIS | Doctors use balloon catheters to open clogged arteries. Now, a Minnesota start-up hopes to apply the same technology to people who have clogged sinuses.

Entellus Medical Inc., based in Maple Grove, Minn., has developed what it bills as a cheaper and less- invasive away to treat sinusitis, or severe chronic sinus infections.

The procedure involves inserting a balloon catheter into the nasal cavity through a tiny incision under the lip, expanding the balloon in the passageway and draining excess mucus from the sinus.

Entellus officials say the treatment, called FinESS, could be a better option than outright surgery; FinESS can be done in a doctor's office using local anesthesia.

"Patients can recover in hours versus days," said CEO Thomas Ressemann. "The balloon lends itself nicely to an office procedure, because there is less bleeding and no cutting of tissue."

Entellus said in June that it raised $15 million more in venture financing from Montagu Newhall Associates, Split Rock Partners and SV Life Sciences. The company is testing FinESS on 100 patients in 16 states and hopes to publish the data this year in a peer-reviewed journal.

FinESS has received approval from the U.S. Food and Drug Administration, and Entellus hopes to secure Medicare reimbursement for the procedure by 2009.

But one expert says FinESS would help only a small percentage of people who suffer from chronic sinusitis. And it's too early to know whether patients' nasal passages will close again after the balloon is removed, said Dr. Steven Koutroupas, an ear, nose and throat specialist at Allina Medical Clinic in Coon Rapids.

The idea for Entellus came in a roundabout fashion. In 2006, Mr. Ressemann and co-founder Peter Keith approached Josh Baltzell, a managing director at Eden Prairie-based Split Rock Partners, with an unrelated idea.

Mr. Baltzell passed on the deal, but he suggested the duo take a look at the ear, nose and throat market, an area that is only now starting to attract more investor interest.

Mr. Baltzell said he was particularly interested in technology that would allow procedures to be done in an office rather than an operating room, a distinction that could save millions of dollars.

"We are looking for ways to streamline the delivery of health care," he said.

Mr. Ressemann and Mr. Keith zeroed in on chronic sinusitis, a condition that affects an estimated 37 million people in the United States.

Allergies, mold or viruses cause nasal passages to close, trapping mucus in the sinus. The mucus buildup results in an infection.

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