TOLEDO, Ohio, June 18, 2018 /PRNewswire/ -- VentureMed Group, Inc., a medical device company that develops and markets innovative interventional vascular solutions, announced initial enrollment in a new non-randomized, single-site, prospective study to evaluate the safety and efficacy of the FLEX Scoring Catheter with a Drug Coated Balloon (DCB) balloon in the maintenance of arteriovenous access sites.
The FLEX Catheter creates long parallel linear scores in all plaque morphologies to prepare an ideal vessel environment to facilitate angioplasty. Its dynamic technique safely scores difficult, diseased vessels, providing vessel compliance and acute lumen gain.
John Ross, MD, FACS is the Director of the Dialysis Access Institute, in Orangeburg, South Carolina and the principal investigator in the FLEX - Drug Coated Balloon Dialysis ACCESS Stenosis Study (AVAFLEX); the sub investigators are Jalal Eddin E. Hakmei, MD, Mark James Lloyd London, MD, and Mohamed A. Sheta, MD. is expected to enroll fifty patients at the Dialysis Access Institute.
"We see too many challenging stenoses return for repeat intervention," said Dr. Ross. "I hope to show in the AVAFLEX trial that by using two devices, the FLEX dynamic scoring catheter and the LUTONIX drug coated balloon, we can enhance the effectiveness of drug coated balloons alone in treating these patients."
Previously, Dr. Ross authored a poster presentation at the 2018 Vascular Access for Hemodialysis Symposium (VASA), where he discussed retrospective data from twenty-four patients that presented for an arteriovenous intervention. Each patient had vessel preparation with the FLEX Catheter before plain old balloon angioplasty (POBA). He concluded vessel preparation created an optimal environment for angioplasty at lower pressures resulting in a significant reduction in stenosis.
VentureMed Group will be exhibiting at the 2018 Vascular Annual Meeting of the Society for Vascular Surgery (SVS) in Boson, Massachusetts, June 20-23, 2018.
About Arteriovenous Fistulas
Over 2 Million patients globally use hemodialysis to treat end stage renal disease (ESRD).1 Hemodialysis often requires surgically created pathways that connect a vein and artery, called arteriovenous fistulas (AV fistula), to access the vascular system. Over time, the requirement for access can become more frequent, decreasing the intervals between hemodialysis interventions. Due to repeated access, the AV fistula might become damaged and a surgical revision or surgery might be performed. Additionally, blockages or narrowing of the blood vessels can occur, requiring a procedure using a balloon catheter to clear the diseased vessels.
1 U.S. Renal Data System, USRDS 2013 Annual Data Report: Atlas of End-Stage Renal Disease in the United States, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 2014.
About VentureMed Group, Inc.
VentureMed Group is a medical device company, founded in 2012, that develops and markets innovative medical devices for the interventional vascular industry. The company's FLEX Scoring Catheter is a safe and effective vessel preparation device engineered to create parallel micro-incisions, prepping the vessel for angioplasty. The FLEX Scoring Catheter is cleared for sale in the US and carries CE Mark for sales in EU. For more information, visit www.venturemedgroup.com.
Gary L. Smith, CEO
VentureMed Group, Inc.
SOURCE VentureMed Group