Restore Medical’s New Snoring Treatment Cleared by FDA

Restore Medical Incorporated has received 510 marketing clearance from the U.S. Food and Drug Administration for its Pillar Palatal Implant System. This breakthrough minimally invasive treatment is designed to permanently treat socially disruptive snoring, a serious health and lifestyle problem afflicting more than 27 million Americans and their bed partners.

The company is planning a general commercial release of the Pillar system in the second quarter of 2003, initially focusing on otolaryngologists who treat snoring patients. For the first time, patients and their physicians have a minimally invasive snoring treatment option that is designed to produce lasting results after a single, brief, virtually painless procedure, said Restore Medical President and Chief Executive Officer, Susan L. Critzer. Our clinical studies have shown that when our Pillar implants are placed in the patient’s soft palate, they alter the palate’s dynamic response to airflow and substantially reduce the severity of snoring in many individuals.

The highly engineered, cord-like Pillar device is less than one inch long. It is woven from a polyester material that has been used for many years in implantable medical products. The implant procedure is conducted in a physician’s office using local anesthesia. In clinical trials of more than 100 patients, the entire procedure lasted an average of less than 10 minutes. Most patients reported that the procedure was virtually painless and that they were able to resume normal activities and diet the same evening. Unlike previous treatments, the Pillar implant stiffens the soft palate without heating or removing tissue.

Most existing snoring therapies have involved stiffening the palate by scarring and removing tissue. In 2002, an estimated 140,000 such procedures were performed in the United States. These therapies can be effective for some patients, but many have to undergo multiple procedures to maintain any benefit and others see no sustainable benefit at all. The inconsistency in results can be attributed to a variety of factors, including the unpredictability of scarring responses among patients and the body’s natural tendency to remodel scars over time. Because of these drawbacks, only about one-third of patients who see a physician about snoring treatment currently elect to have surgery, said Critzer.

Physicians and their patients need a better solution. With our strong clinical results and a one-time procedure with minimal discomfort, we are offering that solution. Restore Medical believes that its patented implant technology may also be applied in the future to the treatment of Obstructive Sleep Apnea, a condition that repeatedly disrupts sleep. The company is conducting research in this area. In addition, Restore Medical has begun research efforts for the treatment of other upper airway disorders.

About The Author:

Casey Harera is a successful author and regular contributor to http://www.1st-in-wellness.com. Obtaining and keeping good health through healthy living, natural healing, great mental health and healthy finances.

	Snoring Treatment
Restore Medical’s New Snoring Treatment Cleared by FDA