Positive Interim Data from Minnow Medical Peripheral Artery Disease Trial Presented at TCT 2009 Conference
SAN DIEGO--(BUSINESS WIRE)--Sep 30, 2009 - Minnow Medical, Inc., a developer of innovative products to treat artery disease, today announced that positive clinical trial results using the Company's Guided Reshaping Technology (GRT™) to treat peripheral artery disease (PAD) were presented last week at the TCT 2009 Conference in San Francisco.
James R. Margolis M.D., director of research at the Miami International Cardiology Consultants, presented interim data from 78 patients showing 97.5 procedural success rate, improved ‰¥1 Rutherford class at 94%, and that no adjunctive therapies, such as a stent or atherectomy were required. No serious adverse events related to the Minnow Medical device were reported. For those patients where interim 6-month follow-up results are available, the data trend to sustainable improvement.
“The early results with Minnow's product are encouraging. I am looking forward to seeing additional data for this promising new technology,” said Dr. Margolis. “The Guided Reshaping Technology is fast and easy to use, and may become a valuable option in treating PAD.”
The study, which is being conducted at five sites in Germany, Chile, and Argentina, is a prospective, open-label, non-randomized study assessing the safety and effectiveness of Minnow's GRT System in symptomatic patients with previously untreated blockages in their popliteal and superficial femoral arteries. The subjects are followed for six months to determine clinical evidence of restenosis. The Company expects to receive complete six-month follow-up data later this year.
Minnow's GRT System treats arterial disease by precise delivery of controlled, non-ablative radiofrequency (RF) energy to open diseased arteries. The RF energy is delivered through electrodes on the surface of a specially designed disposable angioplasty balloon catheter. Minnow's catheter received the CE Mark for marketing in the European Union in April 2009.
About Minnow Medical, Inc.
Minnow Medical, Inc., headquartered in San Diego, California, is a development-stage company founded in 2003. Minnow Medical is establishing its first products in the treatment of peripheral artery disease. Minnow Medical's extensive experience in cardiovascular biology, radiofrequency energy, and tissue biology, combined with scientific experience in atherosclerosis, has resulted in the development of an advanced technology in the treatment of artery disease.
Contact: Minnow Medical
Sr. Vice President Market Development
Lippert/Heilshorn & Associates
Bruce Voss or Don Markley
Posted: October 2009