Pathway Medical Commences Jetstream G3 Calcium Study

March 28, 2011—Pathway Medical Technologies, Inc. (Kirkland, WA) announced enrollment of the first patient in the company's Jetstream G3 Calcium study. The study is a prospective, single-arm, multicenter registry to evaluate the treatment effects of the Jetstream G3 system in patients with moderate to severely calcified peripheral artery disease (PAD). The study will be conducted at six medical centers in the United States and will initially enroll up to 50 patients. William A. Gray, MD, is the study's principal investigator.

"PAD affects more than 12 million people in the United States alone," commented Dr. Gray. "The current standard of care often involves the use of multiple devices to treat different disease morphologies and extensive recovery times for patients, especially for those with difficult-to-treat blockages. With the Jetstream G3 Calcium study, we hope to demonstrate the efficiency and long-term effectiveness of this single technology capable of treating a broad spectrum of vascular disease patients, including those with moderate to severe calcium build up."

The Jetstream G3 is a front-cutting, catheter-based system that is cleared by the US Food and Drug Administration for atherectomy use in the peripheral vasculature and for breaking apart and removing thrombus in peripheral arteries.

According to the company, the study will evaluate the ability of the Jetstream G3 to effectively remove calcium build up and achieve luminal gain in patients with symptomatic peripheral vascular disease who are undergoing percutaneous intervention. Assessment and quantification of luminal gain and calcium removal in PAD interventions before and after treatment will be determined using intravascular ultrasound. The study also will evaluate the use of Jetstream G3 as an adjunctive therapy and monitor residual diameter stenosis, preservation of runoff, and the incidence of major adverse events up to 30 days.