Healthcare Industry News:  ultrasound 

Devices Interventional

 News Release - March 28, 2011

Pathway Medical Technologies Announces Enrollment of First Patient in JETSTREAM G3 Calcium Study

Multi-Center Study to Evaluate Effects of JETSTREAM G3 Treatment in Patients with Moderate to Severe Calcified Peripheral Artery Disease

KIRKLAND, Wash.--(Healthcare Sales & Marketing Network)-- Pathway Medical Technologies, Inc., an innovator of endovascular treatments for peripheral vascular disease (PVD), today announced enrollment of the first patient in the company’s JETSTREAM G3® Calcium Study, 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. The JETSTREAM G3 Calcium Study 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.

The principal investigator of the JETSTREAM G3 Calcium Study is William A. Gray, M.D., director of endovascular services, Center for Interventional Vascular Therapy at New York-Presbyterian Hospital in New York, N.Y. Investigators include: Malcolm Foster, M.D., interventional cardiologist at East Tennessee Heart Consultants and Baptist Hospital West in Knoxville, Tenn.; Tom Shimshak, M.D., interventional cardiologist and director of the Cardiovascular Laboratory and medical director of the Cardiovascular Institute at Wheaton Franciscan Healthcare, All Saints in Racine, Wis.; Tom Davis, M.D., interventional cardiologist and director of Cardiac Catheterization Lab and Peripheral Interventions at St. John’s Hospital in St. Clair Shores, Mich.; Joseph J. Ricotta II, M.D., director of Clinical Research, Division of Vascular Surgery and Endovascular Therapy at Emory University School of Medicine in Atlanta, Ga.; and Venkatesh G. Ramaiah, M.D., director of Peripheral Vascular Surgery and Endovascular Research at the Arizona Heart Institute in Phoenix, Ariz.

“Peripheral artery disease affects more than 12 million people in the U.S. alone,” said Dr. William A. 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 removes atherosclerotic disease and thrombus in the peripheral vasculature. It actively and simultaneously aspirates (or clears) excised debris, reducing procedure time and cost. The catheter is inserted via a small puncture site in the leg, avoiding open surgical intervention. The System is cleared by the FDA for atherectomy use in the peripheral vasculature and for breaking apart and removing thrombus in peripheral arteries.

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 peripheral artery disease interventions pre- and post-treatment will be determined using intravascular ultrasound (IVUS). In addition, 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. “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. Consequently, we firmly believe that JETSTREAM G3 can significantly improve the way PVD is treated across the globe. Our hope is that this study will help us further demonstrate technology capabilities and patient outcome improvements that will ultimately lead to increased adoption of JETSTREAM G3 at centers across the country.”

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. Additional information about eligibility requirements and exclusions can be found at: http://clinicaltrials.gov/ct2/show/NCT01273623.

About Peripheral Vascular Disease

Peripheral vascular disease (PVD) refers to diseases of the blood vessels outside of the heart and brain and is often associated with a narrowing of blood vessels in the legs, arms, stomach or kidneys. Peripheral arterial disease (PAD) is a type of PVD where fatty buildups (atherosclerosis) in the wall of the artery block the normal flow of blood. PAD can cause pain and eventually lead to immobility in affected limbs. People with PAD often have fatty buildups in the arteries of the heart (coronary artery disease) and of the brain (carotid artery disease) and have a higher risk of death from stroke and heart attack. PAD is estimated to afflict as many as 12 million people in the United States, according to the Society of Interventional Radiology (SIR), and as many as 27 million in Europe and North America combined, according to the American Heart Association. Incidence of PAD is generally higher in older age groups and affects approximately one out of every five people aged 55 and older.

About JETSTREAM

JETSTREAM is a peripheral revascularization catheter designed to remove all kinds of artery-clogging plaque in the lower limbs of patients. This innovative and minimally invasive solution clears blockages in the peripheral vasculature, restores blood flow and effectively treats PVD. JETSTREAM consists of a sterile, single-use catheter and control pod and a reusable, compact console that mounts to a standard I.V. stand. The catheter has a cutting tip that safely debulks and preemptively removes both hard and soft plaque, as well as calcium, thrombus and fibrotic lesions. Excised tissue and thrombus are continually aspirated from the peripheral treatment site through ports in the catheter tip to a collection bag located on the console. The distal portion of the catheter also possesses infusion ports that provide continuous infusion of sterile saline during the atherectomy procedure. Active aspiration is a safety feature that minimizes the risk of distal embolization.

With simple set up and an ergonomic design for easy operation by trained clinicians, JETSTREAM maximizes treatment effectiveness and offers renewed hope for non-surgical candidates and the benefits of a minimally invasive treatment option, including faster recovery and decreased systemic complications.

About Pathway Medical Technologies, Inc.

Pathway Medical Technologies, Inc. was founded to design, market and manufacture medical devices for the treatment of vascular disease. The company’s initial focus is treating peripheral arterial disease (PAD) more quickly and effectively than existing technologies. An estimated 12 million people are afflicted by PAD in the U.S. and that number is projected to grow to over 20 million during the next 10 years. The company’s Jetstream® device allows for a minimally invasive procedure designed to restore circulation in the peripheral arteries by removing both hard and soft diseased tissue. For further information, visit the company’s Web site at www.pathwaymedical.com.


Source: Pathway Medical Technologies

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