KIRKLAND, Washington, October 18, 2011–– Pathway Medical Technologies, Inc., a wholly owned subsidiary of MEDRAD, Inc. - a Business of Bayer Healthcare, today announced initiation of the JET Registry, a national registry focused on tracking patients with symptomatic peripheral arterial disease (PAD) undergoing percutaneous interventions. The JET Registry will enroll up to 500 patients at approximately 75 clinical sites across the United States. Patients will be followed for up to one year post treatment. The first patient was enrolled this month with Dr. Vinay Kumar at South Central Regional Medical Center in Laurel, Mississippi.
The JET Registry is a prospective, multi-center, open-label study that will evaluate clinical outcomes—including long-term patency, Rutherford/ABI scores, stent use, measurement of the amount of calcium removed during treatment, as well as major adverse events (MAEs)—of patients treated with the JETSTREAM System. The primary objective of the Registry is to provide clinicians with critical data and insights on disease management, treatment effectiveness and patient outcomes following intervention. Additionally, patients will be able to provide feedback on their treatment satisfaction and its impact on their quality of life.
The principal investigators for the JET Registry are William A. Gray, M.D., Director of Endovascular Services, Center for Interventional Vascular Therapy at New York-Presbyterian Hospital in New York, N.Y., and Christopher J. Kwolek, M.D., Director of Endovascular Training for the Division of Vascular & Endovascular Surgery at Mass General Hospital in Boston, Mass. and Assistant Professor of Surgery at Harvard Medical School. Additionally, Michael Jaff, D.O., Medical Director of the Vascular Ultrasound Core Laboratory and Associate Professor of Medicine at Harvard Medical School, will participate in the independent analysis for this registry.
“Our goal with the JET Registry is to provide interventionists with a central repository for information about patient and disease response to less invasive percutaneous interventions for PAD,” said Dr. Gray. “There is a growing body of published research suggesting that PAD patients can benefit from non-surgical treatment options and have positive outcomes with shorter recovery and fewer side effects. Ultimately, we believe the registry will be an effective tool that produces scientific data that may help aid clinicians in the treatment decision-making process for PAD sufferers.”
Enrollment in the JET Registry is open to patients eligible for treatment with the JETSTREAM System who meet the criteria for study inclusion. Additional information about eligibility requirements and exclusions can be found at: http://clinicaltrials.gov/ct2/show/NCT01436435.
“Developed as a central repository for critical information about clinical and quality of life outcomes, the JET Registry should broaden our understanding of patient response to percutaneous intervention,” said Kevin Peters, Director, Clinical and Medical Affairs, at Pathway Medical Technologies. “The registry is an important milestone for the Jetstream technology and a big step forward in helping understand treatment options for patients suffering from PAD.”
The JET Registry will be approved by the Institutional Review Board (IRB) of each participating organization and is supported by a Steering Committee that will provide guidance on clinical issues, including data interpretation and analytics reviews. MEDRAD and Pathway plan to publish data from the registry on an ongoing basis.
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 a port in the catheter tip to a collection bag located on the console. Active aspiration is a safety feature that minimizes the risk of distal embolization. The distal portion of the catheter also possesses infusion ports that provide continuous infusion of sterile saline during the atherectomy procedure.
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 PAD
PAD is a condition in which fatty buildup in artery walls blocks the normal flow of blood, causing significant pain and, for some patients, leading to immobility in the affected limbs—the disease is estimated to affect as many as 12 million people in the United States, according to the Society of Interventional Radiology (SIR). The most common intervention for PAD has historically included highly-invasive procedures, such as bypass surgery. More recently, less-invasive techniques have emerged—these involve inserting a catheter through the skin and into the blood vessel to clear a blockage and restore circulation to the extremities. These new, minimally invasive treatment options offer patients faster recovery and decreased systemic complications while delivering renewed hope for non-surgical candidates.
About Pathway Medical Technologies, Inc.
Pathway Medical Technologies, Inc. designs, markets and manufactures 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.
About MEDRAD, INC.
MEDRAD, INC. develops, markets and services medical devices used to diagnose and treat disease. Its product offerings include fluid injection systems for radiology and cardiology, endovascular devices for the treatment of cardiovascular disease, magnetic resonance-compatible accessories and equipment services. MEDRAD is a two-time recipient of the Malcolm Baldrige National Quality Award, the top honor a U.S. company can receive for quality and business excellence (2003 and 2010). The company’s world headquarters is near Pittsburgh, Pennsylvania, in the United States. MEDRAD is a business of Bayer HealthCare. More company information is available at www.medrad.com.
About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. Bayer HealthCare, a subgroup of Bayer AG with annual sales of EUR 16.9 billion (2010), is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Medical Care and Pharmaceuticals divisions. Bayer HealthCare’s aim is to discover and manufacture products that will improve human and animal health worldwide. Bayer HealthCare has a global workforce of 55,700 employees (Dec 31, 2010) and is represented in more than 100 countries. Find more information at www.bayerhealthcare.com.