Laminate Medical provides VasQ™, an extravascular nitinol scaffold implanted around the arteriovenous fistula anastomosis during creation to mechanically stabilize the connection and reduce turbulent shear stress. The device increases primary patency and speeds maturation, lowering repeat interventions, and is reimbursable through Medicare’s Transitional Pass‑Through (C8000) code.
Funding
Funding not disclosed
Founders
Product
Problem
Patients requiring hemodialysis often experience primary arteriovenous fistula (AVF) failure rates as high as 60%, leading to repeated surgical interventions, prolonged catheter use, and increased morbidity.
Solution
Laminate Medical’s VasQ™ is an extravascular nitinol support that is implanted around the artery‑vein anastomosis at the time of fistula creation. The device mechanically stabilizes the connection, optimizes flow geometry, and mitigates turbulent shear stresses that drive stenosis and aneurysm formation. Clinical trials and real‑world studies have shown higher primary patency, faster maturation, and fewer post‑operative interventions compared with standard AVF creation. FDA De Novo clearance, CE marking, and Breakthrough Device designation enable rapid market entry, while a dedicated Medicare Transitional Pass‑Through (C8000) code provides reimbursable payment for the procedure. By integrating into existing surgical workflows, VasQ improves long‑term vascular access durability without requiring additional equipment or training.
Target Audience
The primary customers are vascular surgeons, interventional nephrologists, and dialysis center administrators who create and manage AVFs for hemodialysis patients. Hospital systems and outpatient dialysis facilities seeking to reduce access‑related complications are also key users.
Features
- Nitinol external scaffold designed to encircle the AVF anastomosis, providing radial support and preserving optimal vessel geometry.
- Compatible with both forearm (radio‑cephalic) and upper‑arm (brachio‑cephalic) fistula configurations.
- Implantation performed during standard surgical creation; no extra operative steps or imaging required.
- Demonstrated hemodynamic benefits in MRI‑based computational fluid‑dynamic studies, showing reduced flow disturbances and stable shear stress profiles.
- FDA De Novo and CE‑marked; classified as a Breakthrough Device, supporting accelerated regulatory pathways.
- Supported by multiple randomized and propensity‑matched clinical studies showing increased primary patency and reduced intervention rates up to 36 months.
- Integrated with Medicare TPT billing code C8000, enabling supplemental reimbursement for the device.
- Sterile, single‑use package with ISO 13485‑compliant manufacturing and quality assurance processes.