Femoral System Articles & Analysis
13 news found
“The use of the Surfacer System enabled us to quickly and efficiently obtain central venous access after two previous attempts to recanalize the central vein occlusion using other approaches were ...
“The Surfacer Inside-out system represents a new approach to restore right-sided central venous access in chronic thoracic venous occlusion by the inside-out recanalization technique” stated Dr. ...
The Surfacer System received U.S. FDA De Novo clearance in February 2020. The Centers for Medicare and Medicaid Services (CMS) established a unique Healthcare Common Procedure Coding System (HCPCS) code for procedure associated with the use of the device (C9780) and assigned the procedure to a New Technology APC (1534) effective October 1, 2021 which has a ...
“We report on a patient with a history of multiple central venous catheters which resulted in the development of venous occlusion and the need for the placement of their catheter in a femoral vein. Using the Surfacer System, we were able to cross the patient’s central venous occlusion and obtain central venous access which facilitated the placement of ...
The paper, published in the Journal of Vascular Access, demonstrated the ability to gain long-term vascular access without any significant complications or adverse events from the procedure with the benefit of avoiding the placement of a femoral catheter with its associated disadvantages. “This peer-reviewed paper further demonstrates the versatility the Surfacer ...
Bluegrass Vascular Technologies (Bluegrass Vascular), a private medical technology company focused on innovating lifesaving devices and methods for vascular access procedures, announced today that the Centers for Medicare & Medicaid Services (CMS) has finalized a new Healthcare Common Procedure Coding System (HCPCS) code and New Technology Ambulatory Payment Classification ...
To date, Interventional Cardiologist Chris Metzger, M.D., our principal investigator, and system chair of clinical research at Ballad Health System (Kingsport, TN) has already enrolled 11 patients in the trial in the first two weeks. ...
Prior the procedure described in the paper, the patient was implanted with a leadless pacemaker system due to unsuccessful attempts to gain central venous access using a recanalization procedure. ...
The objective of the SAVE Registry was to report Surfacer Inside-Out® Access Catheter System device performance and safety information for patients with thoracic central venous obstruction (TCVO) requiring central venous access. ...
Food and Drug Administration (FDA) approved Investigational Device Exemption (IDE) study was designed to evaluate the performance and safety of the Surfacer Inside-Out® Access Catheter System (Surfacer System) when used to facilitate central venous access in patients with thoracic central venous obstructions. ...
A fully integrated, extravascular, bioabsorbable femoral access closure system, VASCADE MVP is easy to use and leaves no permanent components behind. The system combines Cardiva’s proven proprietary collapsible disc delivery system and a thrombogenic resorbable collagen patch in an integrated design. ...
Food and Drug Administration (FDA) for the VASCADE® MVP Venous Vascular Closure System. VASCADE MVP is the first and only vascular closure system designed and labeled specifically for multi-site venous closure – for 6-12 French inner diameter sheaths. ...
All patients had multiple (3 or 4) mid-bore (6-12 Fr inner diameter sheath) femoral venous access sites, and were randomized into one of two groups. ...