TVA Medical, a developer of minimally invasive therapies for end-stage renal disease and other potential applications, has secured de novo marketing authorization from the US Food and Drug Administration (FDA) for its everlinQ endoAVF system.
The new minimally invasive technology is said to use magnetic catheters and radiofrequency energy to create an arteriovenous fistula (AVF) for hemodialysis access without open surgery.
The FDA approval allows use of the everlinQ endoAVF system as a class II medical device in the ulnar artery and ulnar vein, enabling to create an endoAVF for hemodialysis use in properly indicated patients.
According to the company, over 400,000 people in the US secure hemodialysis multiple times a week for end-stage renal disease (ESRD) and the current standard vascular access approach uses open surgery to create an AVF for dialysis.
The data from four clinical studies using the everlinQ endoAVF system showed 97% procedural success, 88% fistula maturation at three months and 75% successful cannulation at six months with minimal need for re-intervention, said the company.
Through using an endovascular approach, the everlinQ endoAVF system was developed to create an AVF for hemodialysis access.
Two flexible magnetic catheters will be inserted into an artery and vein in the arm in the procedure. A little amount of radiofrequency energy will be needed to connect the artery and vein to create the fistula.
Later, the catheters will be removed and brachial vein will be coil-embolized, allowing future dialysis.
The company secured CE mark approval for everlinQ endoAVF system in 2014, while Health Canada Medical Device License in 2016 for ESRD patients.
TVA Medical president and CEO Adam Berman said: “FDA marketing authorization of the everlinQ endoAVF System is a monumental milestone for dialysis patients who now have an alternative AVF option.
“Thanks to extensive collaboration with the FDA, clinical study investigators and clinical advisors, we are thrilled to now partner with the U.S. vascular surgery and nephrology communities to offer an innovative endovascular fistula creation approach.”
Based in Austin of Texas, TVA Medical is engaged in the development of minimally invasive therapies for ESRD and other potential applications such as peripheral vascular disease.