Minimally-invasive cardiac and vascular procedures that require large-bore access are projected to increase significantly in the coming years, potentially up to 6 times. However, these procedures are inherently associated with significant complications concerning the access site to the blood vessel and its safe closure.
Existing closure devices have proven inadequate, with complication rates remaining as high as 22%. These complications lead to extended hospital stays, increased healthcare costs, and elevated morbidity and mortality rates.
Recognizing the persistent unmet need for cost-effective and reliable large-bore closure devices, Novelrad has pioneered a micro-suturing technology which mimics the work of a vascular surgeon with no need to perform open surgery. With a simple click of a button, this technology enables the minimally-invasive placement of a purse-string suture around the access site and affords safe dilation and reliable closure using a single device, thereby significantly reducing complications and benefiting both patients and healthcare systems.
Novelrad´s revolutionary transcatheter suturing technology can address multiple indications in the cardiovascular system, and beyond, creating enormous scalability potential in diverse markets.
With grant-first funding from the EIC Accelerator program, Novelrad will complete the clinical validation of the device and obtain CE marking for market deployment in addition to completing the feasibility phase for the first intracardiac indication e.g. Patent Foramen Ovale (PFO) closure. These advancements will benefit patients, their families and healthcare systems across Europe.
