Durham medtech startup Deep Blue receives FDA clearance for hernia mesh product
Medtech startup Deep Blue Medical Advances can now begin selling a novel hernia mesh product with enhanced anchoring strength following receipt of FDA device (501 K) clearance, which the company announced it had received Tuesday.
The T-Line Hernia Mesh “provides superior anchoring strength and eliminates a key point of failure for conventional mesh fixation,” the Durham-based company says. It is designed to counter “mesh migration, contraction and eventual failure.”
Deep Blue has raised more than $800,000 in funding.
The company was founded in 2014 by Duke plastic surgeon Howard Levinson, MD.
Millions of hernia surgeries are done globally at billions in clinical costs and support a $1.1 billion hernia device market.
In separate efforts, Levinson is working on additional projects including an anti-biofouling Foley catheter, a non-invasive light imaging technology to diagnose skin disorders, and tissue-engineered skin that resists contraction.
“Sewing a bit of each extension into the abdominal wall, in lieu of traditional sutures, significantly increases mesh anchoring strength and thus the durability of the repair,” Levinson says of the T-Line. “We believe this approach will greatly improve patient outcomes without necessitating significant changes to current surgical practice.”
The firm says it plans to launch the T-Line at “selected sites” in the near future.
[Originally posted by WRALTechWire — Aug 11, 2020]