DURHAM, N.C., Aug. 11, 2020 /PRNewswire/ — Deep Blue Medical Advances in the present day introduced it has obtained 510(ok) Clearance from the U.S. Meals and Drug Administration (FDA) for its T-Line® Hernia Mesh with built-in suture-like extensions. T-Line Hernia Mesh offers superior anchoring energy and eliminates a key level of failure for standard mesh fixation – the mesh, suture, tissue interface that usually results in mesh migration, contraction and eventual failure.
Hernia incidence and recurrence is usually an issue following stomach surgical procedure, when stomach strain (e.g. from lifting or coughing) could cause sutures to chop or pull by way of the tissue or mesh. Invented by surgeons, Deep Blue’s large-pore, mid-weight T-Line Hernia Mesh is designed to extend anchoring energy and stop mesh fixation failure. The mesh extensions have 15x extra floor space than conventional sutures and act much like how snowshoes forestall sinking into snow, lowering fixation stress by spreading pressure over a larger space. T-Line mesh extensions are designed to face up to vital stomach pressures (in literature, as much as 50 N/cm of stress), which is helpful for all sufferers, together with Grade II sufferers with comorbidities.
“Stitching a bit of every extension into the stomach wall, in lieu of conventional sutures, considerably will increase mesh anchoring energy and thus the sturdiness of the restore,” stated Dr. Howard Levinson, Deep Blue’s founder. “We consider this method will tremendously enhance affected person outcomes with out necessitating vital adjustments to present surgical apply.”
“In literature, long run hernia restore failure charges are 32% utilizing standard mesh and 63%1 utilizing suture alone, making a multibillion-dollar scientific value to the US healthcare system. Deep Blue’s merchandise improve hernia surgical procedure with a probably vital impression,” stated CEO Invoice Perry. “Moreover, intensive lab and benchtop testing point out that the T-Line Mesh has ~275% larger anchoring energy than customary of care within the perioperative interval. That is at all times necessary, however significantly so within the interval earlier than vital tissue in-growth into the mesh has occurred.”
The corporate expects to clinically launch the product in chosen websites in Q3, 2020.
About Deep Blue Medical Advances: Established in 2015, Deep Blue Medical Advances is devoted to addressing the unacceptably excessive fee of hernia incidence and recurrence. It manufactures the T-Line® Hernia Mesh.
SOURCE Deep Blue Medical Advances, Inc.