News & Events

The U.S. Centers for Medicare & Medicaid Services (CMS) has granted VasQ™ extravascular support device a Transitional Pass-Through (TPT) Payment under billing code C8000 (Support device, extravascular, for arteriovenous fistula (implantable). The code, effective starting October 1, 2024, will provide incremental Medicare reimbursement to medical providers for the creation of an extravascular supported fistula with VasQ in addition to the established payment rate for fistula creation. CMS developed the TPT program to facilitate more immediate access for patients to new and truly innovative devices, like devices in the U.S. Food and Drug Administration (FDA) Breakthrough Devices designation, in which VasQ falls, by allowing for adequate payment to providers while the necessary cost data is collected to incorporate them into the procedure Ambulatory Payment Category (APC) rate. Read the full press release here>>

The first U.S. implantation of VasQ™ 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. Read the full press release here>>

The VasQ External Vascular Support has been granted the US Food and Drug Administration (FDA) for use as an external support for upper extremity arteriovenous fistulas created for vascular access by means of vascular surgery. . The device, designated by the FDA as a Breakthrough Technology, was cleared based on a de novo review of the 144 patient VasQ US pivotal study as well as a track record of safety and effectiveness of use in multiple studies from outside the USA. Read more at Vascular News>>

Laminated has partnered with NHS Supply Chain in a novel approach to allow NHS to evaluate the potential of VasQ to reduce UK healthcare costs while improving patient lives. The NHS reported, "the novel device will be fully introduced to market towards the end of 2023 with support from NHS Supply Chain, helping to reduce infection rates, avoid repeat procedures and save the NHS money." Read more at Renal Interventions>>

A cost-modelling analysis in real-world comparator groups has illustrated a potentially significant financial benefit across the UK healthcare system to using the VasQ external support device (Laminate Medical Technologies) for surgical arteriovenous fistula (AVF) creation as a standard of care compared to traditional techniques. European data supporting this—and positive clinical outcomes associated with VasQ—were presented by Robert Shahverdyan (Asklepios Klinik Barmbek, Hamburg, Germany) at the Vascular Access Society of Britain and Ireland (VASBI) annual scientific meeting (29–30 September, Glasgow, UK). Read more at Renal Interventions>>

Dr. Andrea Remuzzi and his research team at The University of Bergamo have recently published a randomized-controlled MRI-based computational fluid dynamic study in the Journal of Vascular Access that revealed the impact of VasQ™ External Support on fistula morphology and flow. VasQ, a Laminate Medical Technologies device is implanted around the connection between the vein and artery during the creation of an arteriovenous fistula (AVF) for hemodialysis patients with the intent to provide structural reinforcement and promote a more stable flow profile. The MRI study confirmed the device retained a more optimal geometric configuration over the 1-year study period, which promoted a more stable hemodynamic profile. Control patients on the other hand, experienced significant morphological changes, such as atrial "tenting" and angular degradation, that resulted in either an aneurysmal or stenotic AVF with a less stable flow profile.
Read more here>>

The U.S. VasQ™ External Support Comparative Study results were presented this month for the first time globally at the VASA 2022. The study was a propensity-score matched comparison of the VasQ U.S. Pivotal Study single-arm prospective data with untreated contemporary Medicare patients who underwent arterio-venous fistula creation for hemodialysis by the same study surgeons. The study results demonstrated a significant improvement in primary patency and fistula usability with less re-intervention burden within the first 6 months post-creation.
Read more here>>

Dr. Robert Shahverdyan, Head of Vascular Access Center at Asklepios Klinik Barmbek of Hamburg, Germany, in partnership with Dr. Dirk Hentschel, President-Elect of VASA and Interventional Nephrologist at Brigham and Women’s Hospital of Boston, MA, have recently published a retrospective analysis of 150 consecutive radiocephalic (forearm) fistula VasQ™ External Support procedures at Seminars in Dialysis. The newly published data demonstrated that implanting VasQ resulted in 90% of fistulas used for dialysis within a median of 41 days and 84% maintaining secondary patency out to 36 months. The results suggested that the addition of VasQ to Dr. Shahverdyan’s standard of care has helped hemodialysis patients receive more functional fistulas that are durable over the long-term.
Read more here>>

The German Institute for Hospital Remuneration (InEK) has renewed the NUB Status 1 designation of 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. Read more here>>

The FDA has designated Laminate Medical’s VasQ™ External Support for the creation of arteriovenous fistulas (AVF) in hemodialysis patients as a Breakthrough Device. The FDA Breakthrough Device Program is intended to provide patients and doctors timely access to medical devices that are more effective than the current standard of care for life-threatening or irreversibly debilitating diseases or conditions. The designation is also considered by the Centers for Medicare and Medicaid Services as substantiation of clinical improvement in their consideration for providing additional reimbursement for new technologies. The designation was based in part on the breadth of clinical evidence collected so far for VasQ that consistently demonstrates improvement over the standard of care for creating functional AVFs for hemodialysis treatment. Read more here>>

Laminate announced the completion of enrollment into the VasQ external support US pivotal study. The study was conducted at 17 sites across the USA and prospectively enrolled 144 male and female patients in need of an arteriovenous fistula (AVF) for haemodialysis. Both brachiocephalic and radiocephalic AVF patients were included in the study. The patients will be followed for two years with the primary endpoint of primary patency analysed at six months. Read more here>>

More hospitals than ever have achieved NUB Status 1 reimbursement in Germany this year. NUB status is never a guarantee, but Laminate has been consistently successful over the past several years in achieving the additional reimbursement for VasQ. The increase in hospitals will enable us to expand patient access to VasQ across Germany.

Laminate announced the completion enrollment of the VALUE study for the VasQ™ External Support. The post-market study enrolled 80 patients (50 upper arm and 30 forearm fistulas) for sites across Germany, France, Spain and the UK and will be followed for one year. The study is the first prospective study to assess the use of the device in the forearm. The forearm fistula carries a higher risk of primary failure relative to upper arm fistulas but is preferred by surgeons as it preserves more options for the patient’s future access needs. Read more here.

Laminate announced the completion of a capital raising following an investment from the London-based Valiance Asset Management, through its Luxembourg domiciled Life Sciences Global Investment Fund, in addition to the $12 million investment announced earlier this year. This is the first investment by a Valiance fund in an Israeli company. Read more here.

Laminate announced the enrollment of their first forearm fistula patients in their US pivotal trial of the VasQ™ device. The inclusion of the forearm fistula to the US pivotal trial of VasQ represents a significant potential advancement for dialysis patients to help improve their overall care. Read more here.

Laminate announced the raise of $12 million in a new round of financing slated to support its VasQ vascular support device. The round was joined by Asahi Kasei (TYO:3407) and Tal Capital, as well as a number of private investors. Read more here.