News & Events
News
October 1, 2024
VasQ™ Extravascular Support Granted Transitional Pass-Through (TPT) Payment
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>>
January 16, 2024
First U.S. Implantation of VasQ Since FDA De Novo was Granted
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>>
September 27, 2023
VasQ Now Granted FDA De Novo Approval!!
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>>
June 25, 2023
NHS Innovation Services Highlights VasQ as a Case Study for Introducing Innovations to UK
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>>
November 19, 2022
UK analysis of fistula data finds potential seven-figure cost saving with VasQ device
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>>
June 28, 2022
A Randomized MRI-Based Study Reveals VasQ™ External Support Promotes More Stable Hemodynamics than Standard AVFs
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>>
Read more here>>
June 21, 2022
VasQ™ External Support Comparative U.S. Study Demonstrated Greater Fistula Primary Patency and Usability with a Lower Intervention Rate
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>>
Read more here>>
February 9, 2022
Long-term Device Benefits Demonstrated in the Largest VasQ™ External Support Forearm Fistula Real-World Experience Published To Date
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>>
Read more here>>
February 1, 2021
VasQ™ External Support Awarded NUB Status 1 Reimbursement Renewal for 2021 for 321 Hospitals
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>>
June 7, 2020
VasQ™ External Support Awarded Breakthrough Device Designation by the FDA
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>>
February 5, 2020
Enrollment of the VasQ external support US pivotal study now complete
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>>
February 3, 2020
NUB Status 1 Reimbursement Achieved in 288 Hospitals in Germany
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.
December 11, 2019
Enrollment Complete for VALUE, the Prospective EU VasQ™ External Support Post-Market Study
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.
October 23, 2019
Laminate Medical, Developer of the VasQ™ External Vascular Support Device, Has Completed an Investment from Valiance
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.
July 24, 2019
Laminate Medical Technologies announces enrollment of first forearm patients in pivotal trial of the VasQ device
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.
January 31, 2019
Laminate Medical brings in $12m for dialysis vascular support device
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.
Events
December 12-14, 2024
Paris Vascular Insights (PVI)
Join Laminate Medical at the Paris Vascular Insights (PVI) Course happening December 12-14, 2024 at the iconic Carrousel du Louvre to explore the latest advancements in vascular care alongside a global community of experts. See you in Paris!
November 19-23, 2024
VEITHSymposium 2024
November in New York City means the VEITH Symposium is just around the corner and the Laminate Team can't wait to connect with the vascular community! Check out the full VEITH program here and stop by the Laminate booth on Saturday, November 23rd for more information about bringing VasQ into your practice.
November 13-14, 2024
Medical Device Manufacturers Association (MDMA) Reimbursement & Health Policy Conference
Catch our VP of Commercialization, Anthony Rodriguez, on site at the Medical Device Manufacturers Association (MDMA) Reimbursement & Health Policy Conference to contribute to MDMA's mission of promoting innovation and patient access. Will we see you there?
November 1-3, 2024
Texas Society for Vascular & Endovascular Surgery (TSVES) 2024 Annual Meeting
Join us in Austin for the TSVES 2024 Annual Meeting! Interested in connecting with our team? Visit us on site Saturday and Sunday or email info@laminatemedical.com for more information.
October 3-5, 2024
Controversies in Dialysis Access (CiDA) Symposium
See you soon, Washington D.C.! The Laminate team is excited to connect with the dialysis access community at CiDA this year. Stop by the Laminate booth, attend Saturday's Innovation Session VII, "Enhancing an Aggressive CVC Removal Protocol Using Nitinol Extravascular Supported Proximal Ulnar Artery Fistulas" presented by Dr. George Blessios, and don't miss Robert Shahverdyan's breakfast symposium, "Innovation, Intervention, and Improved Fistula Outcomes" on Friday, October 4th at 7:00am. Check out the full CiDA program here>>
September 19-22, 2024
Eastern Vascular Society 38th Annual Meeting
Find the Laminate team in Charleston for the Eastern Vascular Society'a 38th Annual Meeting. Stop by our booth to learn more about bringing VasQ into your practice! Learn More>>
July 10-13, 2024
Rocky Mountain Vascular Society (RMVS) Annual Meeting
The Laminate team is headed to Coeur d'Alene, Idaho for the 44th annual RMVS meeting in July. Stop by our tabletop to chat with us about VasQ or learn more here>>
June 19-22, 2024
SVS-VAM
Chicago here we come! Visit us at SVS-VAM booth #1029 and don't miss Dr. C. Keith Ozaki's presentation, New Technologies for Surgical AV Fistula Creation in Session C11 on Thursday, June 20th at 2:05pm. Check out the full VAM program here>>
May 16-20, 2024
VASA
See you at VASA! The Laminate Team will be attending the 2024 Vascular Access for Hemodialysis Symposium in Atlanta, GA. Find us at our booth and Friday, May 17th, at our Satellite Breakfast Symposium.
April 23-25, 2024
Charing CX
Join us in London for the Charing CX International Symposium! Interested in seeing VasQ in action? Stop by Laminate's demonstration during the Vascular Access Workshop, lead by Nick Inston and Kate Steiner, on Wednesday, April 24th from 8:00am-3:00pm.
March 17-20, 2024
SCVS
We are excited to attend the 51st annual Society for Clinical Vascular Surgeons (SCVS) Symposium in Scottsdale, AZ. Come see our team at booth #7 and don't miss Dr. Alik Farber's presentation, Vascular External Support Reduced Intervention Rate and Time to Achieve Two-needle Arteriovenous Fistula Cannulation in a Multicenter US Study, Monday, March 18th at 12pm during Scientific Session V: Dialysis. Read the Abstract>>
October 26, 2023
CiDA
COME JOIN US IN ATALANTA! CiDA will be our first US conference since the FDA clearance of VasQ. Dr. Robert Shahverdyan will be training on external support usage on Oct 26. We will host a VasQ breakfast panel with Robert Shahverdyan, Alexandros Mallios and Ellen Dillavou, moderated by Stephen Hohmann on Oct 27. Later that day, Dr. Lucas will be presenting VasQ outcomes on the main podium.
September 29, 2023
VASBI
Nick Inston presented his real-world consecutive patient results at VASBI, which confirm the NHS economic modeling showing a significant cost-benefit when using VasQ.
September 9, 2023
Hamburg Dialysis Access Symposium
Dr. Robert Shahverdyan presented VasQ at the first international version of his Hamburg Dialysis Access Symposium a the Asklepios Klinik. He welcomed guests from the US, UK, Italy, Netherlands and of course Germany.
June 16, 2023
VAM
SVS selected as a plenary talk the complete US Pivotal Study outcomes and the propensity-score matched analysis of VasQ's impact on Medicare claims for VAM to be presented by Dr. Ellen Dillavou.
April 28, 2023
VAS
Dr. Gaspar Mestres was invited to present the potential of VasQ as a new standard for creating fistulas at VAS.
April 28, 2023
VAS
Mr. Nick Inston presented a first look at the beneficial impact of creating fistulas with VasQ on patient outcomes and cost in the UK at VAS.
April 25. 2023
Charing CX
Dr. Ellen Dillavou was invited to present an update on VasQ™ External Support at CHARING CX.
November 23, 2022
PVI
Dr. Alexandros Mallios presented the history of external support to the most current outcomes data for VasQ™ in dialysis access during his invited lectured at PVI. Additional commentary regarding the impact on the UK was delivered by Nick Inston.
November 19, 2022
VEITH
Dr. Ellen Dillavou presented a first look at the health economic benefit of using VasQ™ External Support in a U.S. population during her invited lecture at VEITH.
September 29 – 30, 2022
VASBI
Dr. Robert Shahverdyan presented European data describing the health economic benefit of using VasQ™ External Support at VASBI.
September 20 – 23, 2022
ESVS
Dr. Ellen Dillavou presented the U.S. VasQ™ External Support Comparative Study results at ESVS 2022 in Rome, Italy.
June 10, 2022
VASA
Dr. Keith Ozaki presented for the first time the U.S. VasQ™ External Support Comparative Study results at VASA 2022.
April 27, 2022
Charing CX
Dr. John Lucas presented the first look at the two-year outcomes for VasQ patients from the U.S. Pivotal Study at the 2022 Charing CX Vascular Access Masterclass. Additional on demand abstracts were presented by Dr. Robert Shahverdyan and Dr. Ewa Swiecka based on their real-world experience using VasQ as standard of care for creating arteriovenous fistulas.
February 18, 2022
ASDIN
Dr. Robert Shahverdyan has been invited to share his experience with VasQ as a new frontier in vascular access at this year’s virtual ASDIN meeting.
December 12, 2021
CiDA
Dr. John Lucas presented the most up-to-date data on the VasQ External Support, including the recently released U.S. Pivotal Study data.
November 20, 2021
VEITH
Dr. Ellen Dillavou released the first look at the U.S. Pivotal Study data for the VasQ External Support.
October 21-23, 2021
PVI
Dr. Alexandros Mallios shared a summary of all of the latest data on VasQ, including the recently completed VALUE study.
October 13-16, 2021
DGG
Dr. Vladimir Matoussevitch presented the latest data set from VALUE and Dr. Robert Shahverdyan shared the long-term follow-up of a 150 consecutive VasQ patient cohort.
October 13-15, 2021
SICVE (Caliagri, IT)
Dr. Poala Tabbi presented the recently published multinational real-world study conducted in collaboration with Dr. Gaspar Mestres and Dr. Robert Shahverdyan. Also, Prof. Matteo Tozzi presented the case studies of VasQ used in challenging patients.
September 28-29, 2021
35th Annual European Society of Vascular Surgery Meeting
Join Dr. Gaspar Mestres and Dr. Robert Shahverdyan at ESVS as they present new data on the clinical use of VasQ. Dr. Mestres presented the latest from the VALUE study and Dr. Shahverdyan presented long-term data from the largest cohort of VasQ patients at an individual center to date.
May 21-22, 2021
VASA Spring Symposium
Tammy Gilon, CEO of Laminate Medical, was invited to share how she developed a mechanical solution to the biomechanical mechanisms of fistula failure and brought it to market.
April 19-22, 2021
Charing CX Symposium
Dr. Gaspar Mestres, Clinica Sagrada Familia in Barcelona (SP), and Dr. Ewa Swiecka, Elbe-Elster Kinkikum in Elsterwerda (DE), each presented their own clinical experiences and data with the VasQ External Support.
April 7-8, 2021
12th Congress of the Vascular Access Society
Join Laminate at VAS to hear new VasQ data releases and have interactive discussions with a panel of experts. VasQ Speakers include Dr. Nikolaos Karydis, Guy’s Hospital, UK; Andrea Remuzzi, University of Bergamo, IT; Alexandros Mallios, GH Paris St Joseph, FR; Paola Tabbi, San Giovanni Hospital, IT; Robert Shahverdyan, Asklepios Klinik Barmbek, DE; and Vladimir Matoussevitch, University Hospital Cologne, DE.
Learn more here >>
Learn more here >>
March 7, 2021
24th European Vascular Course (EVC)
Watch Robert Shahverdyan, Andrea Remuzzi, Alexandros Mallios and Jan Tordoir discuss how hemodynamic patterns at the arteriovenous anastomosis impact clinical outcomes in vascular access surgery and to learn how to use the VasQ™ External Support to create a more favorable hemodynamic situation. A recording of the event can be viewed here >>
February 17-21, 2021
17th Annual ASDIN Scientific Meeting
Watch on demand Dr. Andrea Remuzzi share for the first time the interim results of the RESHAPE study, a randomized-controlled trial comparing longitudinal MRI derived geometric and hemodynamic models from AVF patients with and without VasQ™ External Support. 17th Annual Scientific Meeting - American Society of Diagnostic and Interventional Nephrology (asdin.org)
October 10, 2020
VASA Symposium
Dr. Kenneth Woodside joined thought leaders from U.S. and Europe to present the latest news on VasQ and other emerging technologies and procedures for creating dialysis access.
June 27, 2020
Society of Vascular Surgery (SVS) Annual Meeting
Dr. Nicolas Karydis presented an interim update from the VALUE study on behalf of his co-authors (Dr. Gaspar Mestres, Dr. Vladimir Matoussevitch and Dr. Alexandros Mallios) and fellow study PIs.
June 11, 2020
Charing CX Webinar
Watch Dr. Robert Shahverdyan present his perspective on how VasQ works and the impact it has had on his practice for the Charing CX Vascular Access Webinar being hosted in lieu of the in-person congress. A link will be provided once the webinar is live.
February 21-23, 2020
ASDIN, Las Vegas, NV, USA
Come meet our team at the 16th annual scientific meeting in Las Vegas, NV– ASDIN.
We hope to see you there!
We hope to see you there!
January 26-29, 2020
LINC, Leipzig, Germany
Come meet our team at the annual scientific meeting in Leipzig, DE– LINC.
We hope to see you there!
We hope to see you there!