Coaching to develop faster Agency and market access for VenoStent
HOUSTON, TX / ACCESSWIRE / May 17, 2022 / VenoStent, Inc..a clinical-stage tissue engineering company that develops bioabsorbable perivascular wraps to improve the results of 5 million vascular surgeries performed each year, The Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) announced (FDA) provided its novel technology, the SelfWrap® Bioabsorbable Perivascular Wrap, Breakthrough Device Designation (BDD).
“We are very honored that the FDA has recognized the promise of VenoStent’s SelfWrap technology to improve the quality and longevity of patients with chronic kidney disease (CKD) requiring hemodialysis, a life-threatening condition. can be harmful to patients ”said VenoStent CEO, Tim Boire. “About a year ago, we began a clinical trial to evaluate the safety and effectiveness of our new tissue engineering technology to help CKD patients in need of dialysis, and its results. study is very encouraging, in terms of safety and effectiveness.Breakthrough Device Designation is a recognition from the FDA that VenoStent SelfWrap establishes ‘a reasonable expectation of technical and clinical success’ with these clinical outcome and indeed a good potential solution for CKD patients.We look forward to all the benefits provided by this appointment, and the potentially significant impact our device can have on the patient population, as well. others in the future. “
For millions of patients each year, vein grafting offers the best chance of survival. These procedures, such as arteriovenous fistula (AVF) and coronary artery bypass grafting (CABG), use a vein as a replacement artery. Unfortunately, because arteries are not built like arteries, these surgeries can have a much higher failure rate – some more than 50% – further exacerbating disease and death. VenoStent’s device, the SelfWrap, is a macroporous, bioabsorbable polymer wrap that provides scaffolding for these veins, helps them arterialize and can save thousands of lives in the process.
This BDD is an official recognition from the FDA (“the Agency”) that SelfWrap technology may provide for the more effective treatment of a life-threatening or irreversible human disease or condition, with no approved or discontinued alternative available to patients. This includes the use of SelfWrap with VenoStent to improve outcomes in CKD patients who have failed or kidney failure and are referred for surgery to create vascular access because they require hemodialysis treatments to diagnose the toxins in their blood that are normally processed by a healthy kidney. The appointment brings with it a more collaborative relationship with the Agency, the potential for more adaptive clinical trial designs that can expedite FDA approval, and faster mechanisms for reimbursement to facilitate the availability of new, potentially life-saving technologies such as SelfWrap for patients. .
Breakthrough Device Instruction
The Breakthrough Devices Program from the FDA was created to help companies develop promising, novel technologies that treat life -threatening conditions. The benefits of receiving the FDA’s Breakthrough Device Designation include improved access to the Agency with priority review, a faster approval process through the potential for a more efficient and flexible clinical trial design, and the potential for early reimbursement access through Transitional Pass -Through Payment and Transitional Add -On Payment programs provided by the Centers for Medicare & Medicaid Services (CMS). Individually, each of these benefits has implications for new medical technologies. In aggregate, they could change for a company like VenoStent, where all of these program features could be used to benefit a vulnerable patient population.
“This is a huge step in helping patients with kidney disease in the United States. We are grateful to the FDA team, to our own team, and to everyone who has supported us over the years,” said CEO Tim Boire.
VenoStent is a clinical phase tissue engineering medical device company that is developing bioabsorbable smart polymer wraps to modify the outcomes of vascular surgery. The initial focus of the VenoStent is to extend the quality and longevity of dialysis patients with a polymer wrap that wraps around the veins to act as a tissue engineering scaffold and avoid failures. This technique can easily be used to improve the outcomes of vascular surgery for patients suffering from peripheral artery disease (PAD) or coronary artery disease (CAD) and requiring arterial bypass grafting surgery (peripheral artery bypass grafting, PABG). , or coronary artery bypass grafting, CABG.), which gives this technology the ability to treat more than five million patients worldwide.
Some of these statements are forward-looking and the product in question is in the investigation stage. It is not sold in the US or around the world.
See the source version at accesswire.com: