February 10, 2020

Bluegrass Vascular’s Surfacer Inside-Out Access Catheter System Granted FDA De Novo Clearance

February 11, 2020—Bluegrass Vascular Technologies (BVT) announced that the FDA has granted a de novo classification order for its Surfacer Inside-Out access catheter system. The Surfacer system is intended to obtain central venous access to facilitate catheter insertion into the central venous system for patients with upper body venous occlusions or other conditions that preclude central venous access by conventional methods.

The company states that the current approval is based on the results of the SAVE-US investigational device exemption (IDE) trial. Results from this trial include that of the 30 patients enrolled in SAVE-US, 90% met both the primary and secondary efficacy endpoints despite a complex patient population composed largely of type 3 and type 4 obstructions (three or more obstructed vessels). No device-related adverse events were reported, confirming the safety and performance of the Surfacer system, reported Bluegrass Vascular.

“The Surfacer system offers a safe and effective approach to reliably preserve and restore critical upper body vascular access sites,” commented Mahmood Razavi, MD, Principal Investigator of the SAVE-US IDE study, in the company's announcement. “This is an unmet clinical need for patients who require life-saving therapies, such as dialysis, and who have limited options due to venous obstructions.” Dr. Razavi is an interventional radiologist at St. Joseph Hospital in Orange, California.

“Thoracic central venous obstruction (TCVO) is a costly problem associated with increased patient morbidity and reduced quality of life,” added Bart Dolmatch, MD, an interventional radiologist at The Palo Alto Medical Foundation in Mountain View, California. “We’ve recently published reporting standards that create a common language for understanding and describing signs, symptoms, functional impairment, and anatomy of TCVO. BVT incorporated elements of these reporting standards into the SAVE-US trial, demonstrating the clinical impact of the Surfacer system. Now that it has been FDA cleared, the Surfacer will be part of the treatment algorithm for my patients with TCVO.” More information on the TCVO reporting standards can be accessed here

Bluegrass Vascular advised that the Surfacer system will be available in select United States centers in the coming months.

The system received European CE Mark approval in 2016 and is available in Europe, Canada, Singapore, and the Middle East. The Surfacer system is distributed in Europe by Merit Medical.


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