Bluegrass Vascular Technologies Completes Enrollment Of International Post-Market SAVE Registry With Early Positive Results

B2B Training: What’s the Most Effective Way of Learning?

B2B training, which is short for business-to-business training, is a popular and convenient type of training that enables entire companies to train their teams...

AlixPartners Forecasts: Household Products Could Cost U.S. Manufacturers and Consumers 15% More This Year Due to Resin Shortage

While companies can’t control the market forces at play, they can take action to mitigate the risk and impact of supply chain disruption.

October 15, 2018

Bluegrass Vascular Technologies reports enrollment has been completed, of its prospective, multicenter, post-CE Mark, international SAVE (Surfacer® System to Facilitate Access in VEnous Occlusions) Registry. In addition, the company also announced expanded patient enrollment and study sites in the SAVE-US (Surfacer System to Facilitate Access in VEnous Occlusions – United States), a pre-market investigational device exempt (IDE) Study. Positive results and trends were respectively demonstrated in both studies with use of the Surfacer® Inside-Out® Access Catheter System, a novel device designed to facilitate reliable upper body central venous access suitable for patients with upper body venous occlusions or other conditions that preclude central venous access by conventional methods.

“Completing the post-market SAVE study reinforces the Surfacer System as the standard of care for central venous obstruction, a serious challenge in the management of hemodialysis patients,” stated Maurizio Gallieni, MD, Director of the Nephrology and Dialysis Unit at San Carlo Borromeo Hospital in Milan, Italy and one of the investigators of the SAVE study. “It offers a proven and important means of gaining reliable and repeatable central venous access in patients who otherwise have very limited options.”

Of patients enrolled in the international SAVE registry, central venous catheters were placed according to labeled indications in 29 of 30 patients with a 100% success in achieving patency and access. Absence of adverse events in data reported for all treated patients with a single conversion in one patient (3%) with a significant vascular anomaly preventing access. All primary safety and performance endpoints were met in 29 of 30 patients. Patients presented with a variety of occlusion types, including 16 patients (30.2%) with bilateral internal jugular (BIJ) and subclavian (SC) occlusion, 17 patients (32.1%) with brachiocephalic (BC) occlusion, 12 patients with (22.6%) superior vena cava (SVC) occlusion above the azygos and 8 patients (15.1%) with total occlusion of the SVC.

The expanded enrollment in the U.S. IDE to six sites in its 30-patient SAVE-US pivotal trial will continue to evaluate the safety and efficacy of the Surfacer System as demonstrated in the international SAVE registry.

“Central venous occlusion is a major clinical problem for dialysis patients,” stated Dr. Eric Peden, MD, Vascular Surgeon at Houston Methodist Hospital in Houston, Texas and one of the first enrolling SAVE-US IDE investigators. “Early results of the Surfacer System are very encouraging. I look forward to supporting the study to its completion.”

“These are major milestones for our company and for patients with occlusive disease. I am extremely pleased by the early positive results of the international SAVE registry and similar positive trends observed in the SAVE-US IDE study,” stated Gabriele Niederauer, Ph.D., CEO and President of Bluegrass Vascular. “As we near FDA approval, we look forward to supporting our clinical efforts in the U.S. and building on the commercial momentum in Europe.”

spot_img

DON'T MISS

Mediclinic Appoints 2 New Independent Non-Executive Directors

Natalia Barsegiyan and Zarina Bassa will bring significant and diverse skills and experience, complementing those of existing Board members. I am confident they will both be great additions to our Board of Directors.”

Asensus Surgical Appoints Two New Board Members

Asensus Surgical, Inc. (NYSE American: ASXC), a medical device company that is digitizing the interface between the surgeon and the patient to pioneer a new era of Performance-Guided Surgery™, today announced the expansion of its Board of Directors, appointing...

Our Sister Publication: Biotechnology News Magazine

Subscribe to Medical Device News Magazine here.