VenoStent Technology Receives Breakthrough Device Designation by FDA
Designation to promote faster agency and market access for VenoStent
HOUSTON, TX / ACCESSWIRE / May 17, 2022 / VenoStent, Inc..a clinical tissue engineering company that develops bioabsorbable perivascular wraps to improve results in the 5 million vascular surgeries performed each year, announces that the Center for Radiological Devices and Health (CDRH) of the Food Administration and Medicines (FDA) has granted his novel. technology, SelfWrap® bioabsorbable perivascular wrapper, Innovative Device Designation (BDD).
“We are honored that the FDA recognizes the promise of VenoStent’s SelfWrap technology to improve the quality and longevity of patients with chronic kidney disease (CKD) who require hemodialysis treatments, a life-threatening condition that can be devastating for patients, “says VenoStent. CEO, Tim Boire. “About a year ago, we embarked on a clinical trial to evaluate the safety and efficacy of our new tissue engineering technology to help patients with CKD who need dialysis, and the results of this study are very Breakthrough Device Designation is an FDA recognition that VenoStent SelfWrap has established “a reasonable expectation of technical and clinical success” with these clinical results and is, of course, “We look forward to the full benefits of this design and the potentially profound impact our device can have on this patient population, as well as others in the future.” .
For millions of patients each year, the vein graft offers the best chance of survival. These procedures, such as arteriovenous fistula (AVF) creation and coronary artery bypass grafting (CABG), use a vein as a replacement artery. Unfortunately, because the veins are not built like arteries, these surgeries can have extremely high failure rates, some more than 50%, greatly increasing morbidity and mortality. VenoStent’s device, SelfWrap, is a macroporous, bioabsorbable polymer wrap that provides scaffolding for these veins, helping them arterialize and potentially save thousands of lives in the process.
This BDD is an official recognition by the FDA (“the Agency”) that SelfWrap technology can provide a more effective treatment for a life-threatening or irreversibly debilitating or debilitating human disease, without any approved or approved alternative. available to patients. This includes the use of VenoStent SelfWrap to improve outcomes in patients with ERC who have failed or failed kidneys and are referred to vascular access surgery as they require hemodialysis treatments to filter out toxins. of the blood that healthy kidneys would normally process. The designation involves a more collaborative relationship with the Agency, the potential for more adaptive clinical trial designs that can accelerate FDA approval, and faster reimbursement mechanisms to accelerate the availability of life-saving innovative technologies. as SelfWrap for Patients. .
Designation of the innovative device
The FDA’s Breakthrough Devices program was created to help companies develop promising new technologies to deal with life-threatening conditions. The benefits of receiving an innovative device designation from the FDA include improved access to the agency with priority review, an accelerated approval process, and the potential for more efficient and flexible clinical trial design. possibility of access to an early repayment through the transitional payment and the transitional addition. -Payment programs provided by the Medicare and Medicaid Service Centers (CMS). Individually, each of these benefits has an impact on new medical technologies. Taken together, they can be transformative for a company like VenoStent, where all of these program features can be leveraged for the benefit of a very vulnerable patient population.
“This is an important step in helping patients with chronic kidney disease in the United States. We are grateful to the FDA team, our own team, and all those who have supported us over the years,” says CEO Tim Boire. .
VenoStent is a clinical-tissue tissue engineering medical device company that develops bioabsorbable smart polymer wraps to transform the results of vascular surgery. VenoStent’s initial focus is to extend the quality and lifespan of dialysis patients with a polymer wrapper that surrounds blood vessels to act as a scaffold for tissue engineering and prevent failure. This approach can be easily adopted to improve the results of vascular surgery for patients with peripheral artery disease (PAD) or coronary artery disease (CAD) and require arterial bypass surgery (peripheral artery bypass grafting). , PABG or coronary artery bypass graft, CABG). ), giving this technology the ability to treat more than five million patients worldwide.
Some of these statements are forward-looking and the product under discussion is under investigation. Not available for sale in the US or worldwide.
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