Le Lézard
Classified in: Health, Covid-19 virus
Subjects: PDT, FDA

First U.S. Implantation of VasQtm Since FDA De Novo was Granted


SPARTANBURG, S.C., Jan. 16, 2024 /PRNewswire/ -- The first U.S. implantation of VasQtm since FDA De Novo was granted was successfully performed by Dr. Ari Kramer, Director and principal surgeon of Vascular Access Surgery at Spartanburg Regional Hospital in Spartanburg, SC. Developed by Laminate Medical Technologies, this groundbreaking technology represents a pivotal advancement in vascular access procedures in the United States as it is the only approved product designed to assist surgical fistula success from the point of creation. 

VasQ is a nitinol-based external support device for the artery and vein anastomosis during the surgical creation of an arteriovenous fistula to promote maturation into a functional access for hemodialysis. The device was designed to provide structural reinforcement of the mobilized vessels and guides a more stable arterial flow profile as it transitions into the vein.

The importance of this innovation has been underscored by the surge in use of central venous catheters (CVC) during the COVID-19 pandemic, leading to heightened risk of infection and mortality. Creating more functional fistulas with the assistance of a device like VasQ should help to reduce the CVC exposure for this patient population.

Dr. Kramer expressed his enthusiasm for the transformative impact of VasQ on patient care, stating, "I am excited to revolutionize the standard of care for our fistula patients with VasQ. I firmly believe that this device offers my patients the optimal prospects for a sustained, well-functioning fistula with reduced complications and the need for additional procedures."

In a statement, Laminate CEO, Tammy Gilon, hailed the successful completion of the inaugural VasQ case in the United States as a monumental achievement for Laminate Medical Technologies. Gilon remarked, "This accomplishment represents the culmination of 12 years of dedicated effort, and we are elated to introduce VasQ to the US population."

About Laminate Medical Technologies
Founded in 2012 by Tammy Gilon and Dr. Eyal Orion, Laminate Medical Technologies is committed to advancing arteriovenous fistula (AVF) function for hemodialysis patients. Building on the success of VasQ, the company is actively engaged in the development of additional devices designed to address the multifaceted challenges faced by AVF patients.

To see a demonstration video of VasQ, visit https://www.youtube.com/watch?v=2W3HoTH2x58. Visit Laminate at www.laminatemedical.com.

SOURCE Laminate Medical Technologies


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