New Zealand medtech start-up Avasa has finalised the design of the world’s first arterial coupler.
The company said the development signals the transition to pre-FDA submission testing to take the device into clinical use.
“The design freeze is a really exciting milestone – it has taken years of unrelenting design and testing to get here,” said CEO Dr Nandoun Abeysekera.
The device is designed to address a common challenge in microsurgery: connecting small arteries and veins.
The current method involves manual suturing of arteries, which is time-consuming and requires 40 minutes per connection. The Avasa coupler simplifies and expedites this process, with preclinical animal studies showing it can reduce procedure time by 80 per cent and has so far demonstrated a high success rate.
Dual-trained as both a biomedical engineer and physician, Dr Abeysekera felt compelled to build a solution after experiencing this challenge while practising as a plastic surgery resident.
“With a validated preproduction device, successful preclinical trials, and conclusive guidance from the FDA, we can now execute on the formal testing needed for FDA clearance and bring this important technology into the hands of surgeons,” he said.
Avasa said the coupler has undergone pre-submission reviews with the FDA, which has indicated it can follow the 510(k) pathway, which offers a fast route to market clearance.
According to Dr Abeysekera, nearly 90 per cent of more than 100 surgeons surveyed from leading institutions such as MD Anderson, Brigham & Women’s, and Sloan Kettering wanted an arterial coupler and consider it likely to become the standard of care.
Professor Jon Mathy, a Harvard and Stanford-trained plastic surgeon with over two decades of experience, said, “When it comes to that type of surgery aimed at restoring form and function, particularly after cancer and trauma, this coupler provides value by assisting the surgeon and ensuring that blood flow remains patent after this free tissue transfer procedure."
“Reducing operating time is important for the patient. The less time in theatre, the less fatigue and opportunities for complications, the better,” said Professor Mathy.
Avasa is in the process of raising their Series A funding round.