RAQA NEWS ROUND UP - (wc 12.08.19)
FDA Awards Perfuze Stroke Device Breakthrough Status
Perfuze has won FDA breakthrough device designation for its Millipede CIS system for treating acute ischemic stroke.
The catheter-based technology is designed to remove blood clots from the brain after suffering an acute ischemic stroke, restoring vital blood flow.
The company managed to raise approximately $3m in funding for the device however now faces the challenge of entering a crowded field with competition from Johnson & Johnson, Medtronic and Stryker.
European CE Mark Approval for Vascular Graft Solutions Fistula Repair Device
Vascular Graft Solutions has gained CE Mark approval for its FRAME FR external support system for the treatment and repair of AV fistulas.
“We are excited to launch the FRAME FR platform, a holistic solution for repair, stabilization and prevention of recurrent vascular access disease,” said Dr. Eyal Orion, founder and CEO of Vascular Graft Solutions.
The company presented results from an initial study at the April 2019 Vascular Access Society meeting and showed "flow rates were markedly reduced postoperatively in all patients with an average reduction of 69% to normal flow, with all patients reporting relief in their cardiopulmonary symptoms.”
“In the past 10 years, we have become a global leader in developing and commercializing external supports for the prevention of vein graft disease in coronary and peripheral bypass. After extensive pre-clinical and clinical research, we are glad to expand our solutions to hemodialysis patients and hope to address one of the leading causes of morbidity and mortality in these patients – the toxic effect of the vascular access on the heart.
Our solution reduces and maintains the flow within a normal range and has potential to minimize venous re-modelling and mitigate intimal hyperplasia as shown in different pre-clinical and clinical settings studying external support of vein grafts.”
ExThera Medical Gains CE Mark for Blood Filter Device
ExThera Medical's Seraph 100 Microbind Affinity Blood Filter device has won CE Mark approval. The device is designed to reduce pathogens during bloodstream infections (BSI) and lowers the levels of bacteria and viruses present.
“Today marks a definite turning point in advancing the care of bloodstream infections, the result of years of dedicated research, development and investment,” president and CEO Bob Ward said in a press release. “Seraph 100 provides an innovative therapy for rapid and effective treatment of infections that might otherwise prose a devastating risk to patients. We look forward to Seraph 100’s continued success in Europe, while demonstrating its potential to help healthcare providers and their patients around the world.”
NvisionVLE Imaging System Wins FDA Clearance
NinePoint Medical has annouced it gained FDA clearance for its NvisionVLE Imaging System for use in bile ducts and the pancreas.
The device uses a catheter tip to rotate a light beam which in turn provides a real-time, high-resolution image of the tissue surface.
The clearance is in addition to already existing indications for esophageal use with NinePoint’s Optical Coherence Tomography imaging platform and Low-Profile Optical Probe.
This new clearance will allow physicians to use the imaging to see small anatomies such as the pancreatic-biliary system.
NinePoint Medical president and CEO Eman Namati said: “This past year has been especially fruitful, with the clearance and market launch of a first-of-its-kind artificial intelligence technology, and now with the clearance of a pancreaticobiliary application for the Low-Profile Optical Probe.
“The ability to promote this new anatomical space really strengthens the platform of the NvisionVLE Imaging System and continues to build the opportunity for this technology to help patients.”