Surgeons at Deep Blue have developed T-Line Hernia Mesh to provide enhanced anchoring strength and avoid failure of mesh fixation
Deep Blue Medical Advances has obtained the US Food and Drug Administration (FDA) 510(k) approval for its T-Line Hernia Mesh with integrated suture-like extensions.
The surgical instruments maker said that its new T-Line Hernia Mesh will provide enhanced anchoring strength and differs from traditional mesh fixation, by eliminating a key point of failure, the mesh, suture, tissue interface, which may cause mesh migration, contraction and result in its failure.
Deep Blue founder Howard Levinson “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. We believe this approach will greatly improve patient outcomes without necessitating significant changes to current surgical practice.”
T-Line mesh has extensions covering 15 times more surface area than traditional mesh
The occurrence and recurrence of Hernia after abdominal surgery has become a major issue, as abdominal pressure may result in sutures to cut or pull through the tissue or mesh.
Surgeons at Deep Blue have developed the T-Line Hernia Mesh with large-pore, medium weight to to provide enhanced anchoring strength and avoid failure of mesh fixation.
The new mesh features extensions with 15 times more surface area than traditional sutures, aimed at spreading force over larger area to reduce the fixation stress.
Deep Blue said that its T-Line mesh extensions are designed to resist abdominal pressure of up to 50N/cm stress, to benefit all types of patients, including Grade II patients with comorbidities.
The company is planning to commercialise the product in selected sites in third quarter 2020.
Deep Blue CEO Bill Perry said: “In literature, long term hernia repair failure rates are 32% using conventional mesh and 63%1 using suture alone, creating a multibillion-dollar clinical cost to the US healthcare system. Deep Blue’s products enhance hernia surgery with a potentially significant impact.
“Furthermore, extensive lab and benchtop testing indicate that the T-Line Mesh has ~275% greater anchoring strength than standard of care in the perioperative period. This is always important, but particularly so in the period before significant tissue in-growth into the mesh has occurred.”