Pathway Medical Technologies, which specializes in endovascular treatments for peripheral vascular disease (PVD), announced it has enrolled the first patient in the company’s JETSTREAM G3 Calcium Study.
JETSTREAM G3 Calcium Study is a prospective, single-arm, multi-center registry to evaluate the treatment effects of the JETSTREAM G3 System in patients with moderate to severely calcified peripheral artery disease. JETSTREAM is a peripheral revascularization catheter designed to remove all kinds of artery-clogging plaque in the lower limbs of patients.
With this Study, the team hopes 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 study plans to enroll up to 50 patients initially. It will be conducted at six medical centers across the United States and will initially enroll up to 50 patients. The first patient was enrolled by Dr. Malcolm Foster at East Tennessee Heart Consultants and Baptist Hospital West in Knoxville, Tenn.
“Peripheral artery disease affects more than 12 million people in the U.S. alone,” said Dr. William A. Gray, principal investigator of the JETSTREAM G3 Calcium Study. “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.”
The JETSTREAM G3 is a front-cutting, catheter-based system that removes atherosclerotic disease and thrombus in the peripheral vasculature. The focus of the study is to 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.
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 (MAEs) up to 30 days.
“The initiation of the JETSTREAM G3 Calcium Study is a major milestone for Pathway,” said Pathway Medical Technologies President and CEO Paul Buckman, in a statement. “The JETSTREAM is already highly effective in many lesion morphologies.”
“Now, with product improvements made to our third-generation ‘G3’ catheter, the JETSTREAM has the potential to easily tackle even heavy calcium,” Buckman added. “Consequently, we firmly believe that JETSTREAM G3 can significantly improve the way PVD is treated across the globe.”
According to Buckman, the study will help the team further demonstrate technology capabilities and patient outcome improvements that will ultimately lead to increased adoption of JETSTREAM G3 at centers across the country.
Pathway Medical Technologies announced that enrollment in the JETSTREAM G3 Calcium Study is open to any patients eligible for treatment with the JETSTREAM G3 System who meet the inclusion criteria.
Eligibility requirements and exclusions can be found at this website.
In February, Pathway Medical Technologies formed a partnership with Omnify Software, a provider of Product Lifecycle Management (PLM) software, to use Omnify Empower PLM solution to automate product development processes at Pathway.
Rajani Baburajan is a contributing editor for HealthTechZone. To read more of Rajani's articles, please visit her columnist page.Edited by
Janice McDuffee
