PerQseal Blue, an investigational device being developed by Vivasure Medical, is designed for fully absorbable, sutureless, large-bore venous closures. The company announced its plans to begin a study to assess and optimize PerQseal Blue to promote its venous program to the clinical stage in 2022.
PerQseal vascular closure device
Large-bore arterial vessel access is needed in transcatheter endovascular procedures such as thoracic endovascular aneurysm repair, transcatheter aortic valve repair or replacement, and endovascular abdominal aneurysm repair. For assisting these procedures, Vivasure Medical's PerQseal vascular closure device is approved and available to physicians, in Europe, for use in femoral arteries. The PerQseal Blue technology is derived from this device.
Percutaneous cardiovascular procedures like transcatheter tricuspid valve repair or replacement and transcatheter mitral valve repair or replacement involve venous closure, which can be achieved by the completely absorbable, sutureless PerQseal Blue.
The vein is returned to its natural state by sealing it from within using an intravascular patch component of the PerQseal Blue. Vivasure medical states that for percutaneous cardiovascular procedures like valve repair or replacement, the synthetic implant PerQseal Blue has the potential to attain a large-bore venous closure in a sutureless and completely absorbable way.
European Innovation Council Accelerator (EIC) granted a fund of €2.5 million for the PerQseal Blue development program initiated in 2020. The EIC supports scientists, small companies, and innovative entrepreneurs planning to expand globally. It is a part of the European Commission's Horizon 2020 program.
Azeem Latib, MD, section head of Interventional Cardiology and Medical Director of Structural Heart Interventions at Montefiore Medical Center in New York, commented in Vivasure Medical's press release that there is a rising requirement for new venous closure options as the popularity of transcatheter procedures for mitral and tricuspid valve treatment grows. Vascular complications can often be caused in these minimally invasive procedures as they require larger punctures. PerQseal Blue can provide a simple and safe option for venous closure without leaving metal implants, sutures, or collagen behind.
Vivasure Medical's next-generation PerQseal+ device with an enhanced bioabsorbable patch will be assessed in Frontier V announced the company in April.