BERLIN, Feb. 1, 2021 /PRNewswire/ -- The German Institute for Hospital Remuneration (InEK) has renewed the NUB Status 1 designation of Laminate Medical's VasQ™ External Support for 2021. NUB Status 1 provides supplemental reimbursement for innovative medical devices that have the potential to improve the standard of care for patients. VasQ™ External Support first received NUB Status 1 in 2017 with 35 participating hospitals. It has since grown to 321 participating hospitals to date, which is the second highest among devices that serve the dialysis patient population.
The VasQ™ External Support is implanted around the anastomosis during the creation of an arteriovenous fistula (AVF) to promote more usability without the need for the frequent additional procedures typically required for standard AVFs. In seven clinical studies, VasQ AVFs have reported usability rates as high as 86% or better by 6 months. Growing clinical evidence in support of VasQ, as well as the building momentum of usage in InEK calculating hospitals are critical components to support a permanent DRG code for reimbursement.
"My practice relies on VasQ as our standard of care for creating almost all of our forearm and upper arm surgical fistulas," stated Dr. Robert Shahverdyan, Head of Vascular Access Center Hamburg at Asklepios Klinik Barmbek. "The device has improved my fistula outcomes for my patients, and I am grateful for the NUB designation so my work with VasQ can continue with sufficient reimbursement to cover the additional costs of the device."
The device is currently being implanted across Europe under a CE mark and has also completed enrollment in an IDE pivotal clinical study to be evaluated by the FDA through the De Novo Pathway for use in the U.S.. The FDA has already awarded the device a Breakthrough Designation based on the breadth of clinical evidence collected so far for VasQ that consistently demonstrates improvement over the standard of care for AVF creation. This designation provides VasQ with the substantiation of clinical improvement required by the Centers for Medicare and Medicaid Services for providing additional reimbursement for new technologies once cleared for the U.S. market.
"We are excited by the growing interest in Europe, particularly Germany and the growing number of hospitals participating in the successful NUB Status 1 renewal. We are grateful for the partnership this designation represents with surgeons, hospitals, and payers to continue to enable patient access to VasQ," stated Oliver Baumgaertner, VP of Sales and Marketing for Laminate.
About Laminate Medical Technologies
Laminate Medical Technologies is dedicated to making fistulas better for hemodialysis patients. Founded in 2012 by Tammy Gilon and Dr. Eyal Orion, Laminate plans to build upon the success of VasQ with additional devices currently in development to address the challenges faced by AVF patients.
SOURCE Laminate Medical Technologies