Laminate Medical Technologies News
17 articles
VasQ™ Extravascular Support Granted Transitional Pass-Through (TPT) Payment
Laminate Medical Technologies announced that the U.S. Centers for Medicare & Medicaid Services (CMS) has granted a Transitional Pass-Through (TPT) Payment for their VasQ™ extravascular support device, effective October 1, 2024. This decision, supported by the American Association of Kidney Patients (AAKP), allows for incremental Medicare reimbursement for the device, which aims to improve outcomes for dialysis patients. The TPT Payment is expected to facilitate quicker access to this innovative technology, which has been granted FDA De Novo status. The decision is seen as a significant step forward in improving patient outcomes and reducing healthcare costs. Laminate Medicals CEO, Tammy Gilon, expressed gratitude to the patients and organizations involved in advocating for this change.
First U.S. Implantation of VasQ™ Since FDA De Novo was Granted
Laminate Medical Technologies has achieved a significant milestone with the first U.S. implantation of its VasQ device, following FDA De Novo approval. This device, designed to enhance the success of surgical fistulas, was successfully implanted by Dr. Ari Kramer at Spartanburg Regional Hospital. The VasQ device aims to improve patient outcomes by reducing complications and the need for additional procedures, particularly important in the context of increased central venous catheter use during the COVID-19 pandemic. Laminates CEO, Tammy Gilon, highlighted this achievement as the result of 12 years of dedicated effort. The company continues to develop solutions for arteriovenous fistula challenges, reinforcing its commitment to advancing hemodialysis patient care.
Laminate Medical announces FDA clearance for VasQ AVF creation device - Vascular News
Laminate Medical Technologies has received FDA clearance for its VasQ External Vascular Support device, designated as a Breakthrough Technology. This device is used to create arteriovenous fistulas (AVFs) for dialysis access. The approval was based on a de novo review of a pivotal study involving 144 patients, demonstrating improved primary patency and functional success compared to traditional AVFs. The device showed no serious adverse events over a two-year study period. The VasQ device, made from nitinol, provides structural reinforcement and guides stable arterial flow, leading to better clinical outcomes. The clearance allows Laminate to offer this innovative solution to the US dialysis patient population, potentially reducing the need for additional procedures and lowering infection risks.
A Randomized MRI-Based Study Reveals VasQ™ External Support Promotes More Stable Hemodynamics than Standard AVFs
A study by Dr. Andrea Remuzzi and his team at The University of Bergamo has revealed the positive impact of VasQ™ External Support, a device developed by Laminate Medical Technologies, on fistula morphology and flow. The device is implanted during the creation of an arteriovenous fistula (AVF) for hemodialysis patients, providing structural reinforcement and promoting a more stable flow profile. The study found that the device retained a more optimal geometric configuration over a 1-year study period, promoting a more stable hemodynamic profile. Laminate has submitted for market clearance in the U.S. to the FDA.
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Long-term Device Benefits Demonstrated in the Largest VasQ™ External Support Forearm Fistula Real-World Experience Published To Date
Laminate Medical Technologies VasQ External Support has shown promising results in a retrospective analysis of 150 procedures. The device, which is implanted around the connection between the vein and artery of an arteriovenous fistula, promotes maturation into a functional access for hemodialysis. The study, conducted by Dr. Robert Shahverdyan and Dr. Dirk Hentschel, showed that 90% of fistulas used for dialysis became functional within a median of 41 days, and 84% maintained secondary patency out to 36 months. Laminate is currently preparing their submission for market clearance to the FDA.
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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 Laminate Medicals VasQ™ External Support for 2021. This designation provides supplemental reimbursement for innovative medical devices that have the potential to improve the standard of care for patients. 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.
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VasQ™ External Support Awarded Breakthrough Device Designation by the FDA
Laminate Medicals VasQ External Support for arteriovenous fistulas in hemodialysis patients has been designated as a Breakthrough Device by the FDA. This designation provides timely access to more effective medical devices. The designation also supports the consideration of additional reimbursement for new technologies by the Centers for Medicare and Medicaid Services. VasQ has consistently demonstrated improvement over the standard of care for creating functional AVFs for hemodialysis treatment. The device is currently in a pivotal clinical study and is expected to complete follow-up by August 2020. The FDA will evaluate the study results and clinical evidence to grant U.S. market clearance. This milestone will enable a faster regulatory process and reimbursement for the device.
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Published Real-World Experience Demonstrates VasQ™ External Support Improves Outcomes When Adopted as the Standard of Care
Dr. Robert Shahverdyan, Head of Vascular Access Center at Asklepios Klinik Barmbek, published a retrospective analysis of his use of VasQ™ External Support, a technology developed by Laminate Medical, in the Journal of Vascular Access. The analysis showed that using VasQ as the standard of care for radiocephalic fistulas resulted in a significant improvement in primary fistula failure rates and longer-term secondary patency rates. The adoption of VasQ as the standard of care improved patient outcomes. Laminate Medical Technologies aims to improve arteriovenous fistula function for hemodialysis patients and plans to develop additional devices to address the challenges faced by these patients.
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Enrollment of the VasQ™ External Support US Pivotal Study Now Complete
Laminate Medical Technologies has completed enrollment into the VasQ External Support US Pivotal Study, which aims to address the high failure rates of arteriovenous fistulas (AVFs) used in hemodialysis treatment. The study enrolled 144 patients and will follow them for two years to analyze primary patency at six months. AVFs are preferred for hemodialysis due to low infection and mortality rates, but the natural biologic responses often lead to AVF failure. VasQ, a nitinol external support device, is designed to optimize arterial flow to the vein and reinforce the vessel wall, reducing failure rates. The clinical benefits of VasQ seen in Europe are expected to be validated in the US through this study. Laminate Medical Technologies plans to build upon the success of VasQ with additional devices for AVF patients.
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Laminate Medical, Developer of the VasQ™ External Vascular Support Device, Has Completed an Investment from Valiance
Laminate Medical Technologies, an Israeli start-up, has announced the completion of a capital raising following an investment from Valiance Asset Management. This investment marks the first by a Valiance fund in an Israeli company. Laminates flagship device, VasQ, is a dual-component, nitinol external support for arteriovenous fistulas in dialysis patients. VasQ has been successful in European hospitals and aims to reduce the primary failure rate of arteriovenous fistulas. Following the capital raise, Jose Calle Gordo from Valiance will join Laminates Board of Directors. The investment will allow Laminate to focus on marketing efforts in the USA and expand globally. This is Laminates second round of capital raising in less than a year.
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VasQ™ External Support demonstrates significant improvement in fistula usability in the newly published multi-center randomized-controlled study
Laminate Medical Technologies announces enrollment of first forearm patients in pivotal trial of the VasQ device
Israeli vascular support co Laminate raises $12m
Israeli medical device startup Laminate Medical Technologies has raised $12 million in a financing round. The company has developed a vascular support device for patients requiring dialysis. They are currently conducting clinical trials in the US and working towards FDA approval. The product already has CE approval in Europe and is in use in hospitals in Germany. Laminate has expanded its activities in the German market following the approval of additional reimbursement coverage. The company also sells its product through distributors in other countries. The recent investment brings the total investment in the company to $24 million.
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Laminate Medical Technologies rolled out its FDA pivotal trial of the VasQ device - Pharma Journalist
Laminate Medical Technologies, a privately-held start-up, has announced the rollout of its FDA pivotal study for VasQ, an implanted blood vessel external support device for patients requiring arteriovenous fistula for hemodialysis. The device is already in use in hospitals in Europe and Israel and has shown commendable outcomes. The study aims to enroll 129 male and female patients, assessing the primary patency rate 6 months after creation of the arteriovenous fistula. The company is experiencing growth-positive impact as it expands its clinical trials in the US.
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FDA Approves IDE for Clinical Study of Laminate Medical Technologies' VasQ Device - Endovascular Today
Laminate Medical Technologies has received FDA approval to conduct clinical trials for its VasQ device, an implanted blood vessel external support device for patients requiring arteriovenous fistula as vascular access for hemodialysis. The company aims to obtain FDA marketing approval for the device. The VasQ device has already received CE Mark approval and is available in Europe and Israel. The clinical trial will enroll 129 patients and the primary effectiveness endpoint will be the primary patency rate at 6 months after creation of the arteriovenous fistula. The company plans to follow the patients for a total of 2 years.
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Laminate Medical Technologies raises $8m
Israeli medical device startup Laminate Medical Technologies has raised $8 million in a series-B financing round, bringing their total funding to $13 million. The company has developed a blood vessel support device for patients needing dialysis. The device, called VasQ, has obtained CE approval and is in the process of approval by the US Food and Drug Administration. It is already in use in hospitals in Europe and Israel, with positive results. The funding will be used to expand activities in the European market, complete clinical trials in the US, and open a branch in the US.
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5 former Rad BioMed portfolio cos raise $7m
Five former Rad BioMed Incubator portfolio companies have raised $7 million in follow-on investments from Yehuda and Zohar Zisapels RAD Group and private investors. The companies are VGS Ltd., Vectorious Medical Technologies Ltd., Laminate Medical Technologies Ltd., Perflow Medical Ltd., and Moebius Medical Ltd. Eon Surgical Ltd. was sold to Teleflex Inc. in 2013.
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