TVA Medical’s Hemodialysis Access System Demonstrates Success in Clinical Study

Preliminary clinical trial data conducted by TVA Medical Inc. suggests the company’s FLEX System can create vascular access for hemodialysis patients without traditional open surgery.

TVA Medical’s technology is being studied outside of the United States and currently is not available in America. The company intends to use the study data to seek future U.S. Food and Drug Administration of its FLEX System.   

The study demonstrated that TVA Medical’s vascular catheter-based FLEX System can create autogenous arterio-venous fistulas (AV fistulas) for hemodialysis patients with 94 percent procedural success.

Surgical AV fistulas are the current gold standard for hemodialysis access, but they are plagued by high failure rates and frequent revisions resulting in enormous healthcare costs. Patients receiving surgical AV fistulas require an average of two to three additional interventions to achieve a usable fistula¹, which can delay availability of the AV fistula for hemodialysis by five to 12 months.²  Additionally, 30-60 percent of AV fistulas are never usable for dialysis, despite numerous re-interventions.^1,3,4

“The preliminary results of this first in human study demonstrate that we can create usable autogenous AV fistulas without open surgery,” said Dheeraj K. Rajan, M.D., an investigator of the FLEX-1 study and Head of Vascular and Interventional Radiology at University of Toronto, Canada. “Moving to an entirely percutaneous procedure for vascular access has the potential to dramatically improve patient care by improving fistula usability, reducing surgical wait times, and reducing complications and costs.”

“Overall, we are very pleased with the outcomes demonstrated in this clinical study,” said Adrian Ebner, M.D., principal investigator of the FLEX-1 study and Chief of Cardiovascular Services at the Italian Hospital, Asuncion, Paraguay. “Many of these patients were dependent on central venous catheters, and now have a functioning permanent vascular access delivered using a minimally-invasive procedure. I believe many patients worldwide will benefit from this procedure.”

The FLEX-1 Pilot Study is a non-randomized, prospective study on the feasibility of using the FLEX System to create AV fistulas in patients with kidney failure requiring hemodialysis without open surgery.  Sixteen patients were enrolled in the initial cohort and followed for three months. Additional follow-up is ongoing.

“Two million people worldwide rely on hemodialysis three times a week to sustain life, and many are subjected to multiple procedures and long duration on infection-prone catheters while they wait for a permanent workable AV fistula.  There is an unmet need for a reliable, reproducible method to connect patients to the dialysis machine in a timely manner,” TVA CEO Adam L. Berman said. “We believe our technology has the potential to benefit hemodialysis patients around the world.”

The TVA Medical FLEX system uses two vascular catheters, incorporating magnets and an RF electrode, that are delivered percutaneously to an artery and vein in the arm. When the catheters are magnetically aligned and positioned under fluoroscopy, RF energy is delivered to create an arteriovenous fistula without open surgery. No implant is left behind.

More than 2 million end-stage renal disease patients worldwide receive hemodialysis therapy and require vascular access to connect to a dialysis machine. The Centers for Medicare & Medicaid Services spends $47 billion annually to treat patients with end-stage renal disease. Vascular access is the leading cause of hospitalizations and morbidity in patients with end stage renal disease.⁵

Headquartered in Austin, Texas, TVA Medical develops minimally invasive therapies for end-stage renal disease, including a catheter-based AV fistula system. The company was founded in 2008 by serial medical device entrepreneur and cardiovascular surgeon William (Billy) E. Cohn, M.D., Berman, and Sante Ventures. S3 Ventures led the Series B round in June 2013 that included TriStar Technology Ventures and Sante Ventures.

References:
¹ Peterson W., et al.  Clin J Am Soc Nephol.  2008 March; 3(2):437-441.
² Lee T., et al.  Am J Kidney Dis. 2005 Sep;46(3):501-8.
³ Dember LM, et al.  JAMA. 2008 May 14;299(18):2164-71.
⁴ Huijbregts HJ, et al. Clin J Am Soc Nephrol. 2008 May;3(3):714-9.
⁵ CMS Annual Report.  End Stage Renal Disease Clinical Performance Measures Project.  2004.