If you are a tool manufacturer dealing with high complication rates in vascular closure—which can reach 20%—this project developed a micro-suturing device that could reduce those complications to 3%. This allows for safer, faster procedures and better patient outcomes.
Automated Micro-Suturing Device for Closing Large Vascular Access Sites After Heart Surgery
Imagine trying to sew a precise stitch inside a blood vessel using a tiny needle, but doing it through a small tube instead of open surgery. This technology acts like a smart sewing machine for arteries, closing large holes with a simple button click. It replaces manual stitching with a reliable, automated pattern to stop bleeding faster.
What needed solving
Large-bore transcatheter procedures often leave access sites that are difficult to close, leading to bleeding complications in up to 20% of cases and high management costs.
What was built
A Class III medical device for large-bore vascular closure featuring a proprietary micro-suturing system. Deliverables include a production line in a Class 7 clean room and validated article systems.
Who needs this
Who can put this to work
If you are a clinic dealing with high costs of complication management, around 20k per patient, this project developed a closure device that enables same-day discharge. This reduces hospital stay durations and lowers overall healthcare costs.
If you are a company developing larger transcatheter devices that require access sites up to 30Fr, this project developed a versatile closure platform. It ensures that larger bore access does not lead to increased bleeding risks.
Quick answers
How does this device impact the cost of cardiac procedures?
It aims to reduce healthcare costs by enabling same-day discharge and avoiding complication management costs, which currently average 20k per patient.
Can this technology be scaled for different types of heart repairs?
Yes, the platform is designed for scalability; while the first product focuses on vascular access, future applications include repairing intracardiac structures like Patent Foramen Ovale (PFO).
What is the intellectual property or licensing status?
Based on available project data, the company has developed a proprietary micro-suturing technology, though specific licensing terms are not disclosed.
What regulatory hurdles remain for market entry?
The device is categorized as a Class III medical device and requires the completion of clinical trials to obtain CE certification.
What is the timeline for clinical validation?
The project is currently preparing to initiate First-In-Human (FIH) clinical trials following the completion of preclinical studies in early 2025.
Who built it
The project is led by a single Israeli SME, Novelrad Ltd, which holds 100% of the industry ratio. This lean structure suggests a fast-track development cycle where the company maintains full control over the proprietary technology and IP, though it lacks academic or large-scale industrial partners within the EU consortium.
Contact Novelrad Ltd in Israel regarding Class III medical device partnerships.
Talk to the team behind this work.
Contact us to explore licensing opportunities for micro-suturing technology.