Bluegrass Vascular Technologies, Inc. announced today that it has successfully enrolled over one third of its patients in the company’s post-market SAVE (Surfacer® System to Facilitate Access in VEnous Occlusions) Clinical Study. The SAVE study is an international, prospective, multicenter clinical follow-up study designed to confirm clinical performance and safety of the Surfacer® Inside-Out® Access Catheter System, a novel device indicated for obtaining central venous access to facilitate catheter insertion into the central venous system in patients with chronically occluded veins.
Bluegrass Vascular Technologies announced today that it is entering into a strategic relationship with Merit Medical Systems (Merit Medical), a leading manufacturer and marketer of proprietary disposable devices. The agreement will streamline European distribution of the recently CE mark approved Surfacer® Inside-Out® Access Catheter System and will provide funding to support the company’s efforts to secure FDA clearance for product sales in the U.S.
Bluegrass Vascular Secures CE Mark Approval and Announces Successful Commercial Use of The Surfacer® Inside-Out® Access Catheter System
Bluegrass Vascular Technologies today announced that it has received CE Mark approval and is launching limited commercial sale of its Surfacer® Inside-Out® Access Catheter System. The Surfacer System is indicated for obtaining central venous access to facilitate catheter insertion into the central venous system via a novel Inside-Out approach.
Bluegrass Vascular Technologies Announces First Clinical Use of the Surfacer® Inside-Out® Access Catheter System in Europe
The Surfacer® Inside-Out Access® Catheter System procedure was performed under Germany’s “compassionate use” program,which grants access to physicians for use of medical devices not yet CE Mark approved in Europe, particularly in Germany, for patients who are diagnosed with advanced diseases and fail to respond to existing treatment options.
Bluegrass Vascular today announced the appointment of Dr. Gabriele Niederauer, a seasoned senior medical device executive, to President and CEO. Following the recent closure of Series A financing, BVT is focused on obtaining CE Mark for the Surfacer™ Inside-Out™ Access Catheter System, a proprietary system that allows physicians to gain venous access using a novel approach.
Bluegrass Vascular today announced it has closed $4.5 million in Series A financing, which was led by Targeted Technology Fund II. Proceeds from the deal will allow Bluegrass Vascular to obtain CE Mark for the Surfacer™ Inside-Out™ Access Catheter System, enhance manufacturing capabilities, and proceed with US regulatory submissions. The Surfacer System is a proprietary system that allows physicians to gain venous access using a novel approach.
Bluegrass Vascular Technologies presented initial first in human results for the Surfacer™ Inside-Out™ Access Catheter System in the poster session today at the 25th Annual International Symposium on Endovascular Therapy (ISET) in Miami Beach, FL. A total of six patients with severe renal disease and upper extremity occlusive disease were treated with 100 percent acute success rate in accessing occluded vessels, maintaining patient safety, and access potency.
Bluegrass Vascular Technologies Begins First Clinical Study of the Surfacer® Inside-Out™ Access Catheter System
Bluegrass Vascular Technologies has announced patient enrollment in the first clinical study of its Surfacer™ Inside-Out Access Catheter System, a proprietary system that allows physicians to perform a novel approach to gain venous access. The prospective single-center feasibility study will evaluate the safety and effectiveness of the Surfacer in up to 10 patients with upper extremity venous occlusion (or blockage in the vein). Conducted by Principal Investigator Dr. Adrian Ebner at the Sanitorio Italiano in Asunción, Paraguay, the study commenced with the successful treatment of six patients in early December.
Therix Medical Spins Out Bluegrass Vascular Technologies, Developer of the Surfacer® Inside-Out™ Access Catheter System
Medical technology incubator Therix Medical has announced the launch of spin-out Bluegrass Vascular Technologies, a stand-alone company dedicated to developing and commercializing life-saving devices and methods that address shortcomings in vascular access procedures. Bluegrass Vascular Technologies’ flagship product is the Surfacer® Inside-Out™Access Catheter System, a proprietary instrumentation set that allows physicians to perform a novel femoral approach to gain venous access.