Tela Bio, Aroa Biosurgery win FDA nod for large-size OviTex bioscaffolds

Tela Bio and its partner Aroa Biosurgery said yesterday that it won FDA 510(k) clearance for large-size OviTex reinforced bioscaffolds intended for soft tissue repair. The OviTex RBS devices are surgical implants with integrated biologic and synthetic materials to allow the movement of fluid and cells through the product, Malvern, Penn.-based Tela Bio said. With the clearance, the companies said that they will now offer the OviTex RBS devices in the US in sizes up to 20×40 cm, a 150% surface area increase over its currently available offerings. “We are pleased to launch larger OviTex RBSs as we continue our mission to provide valuable solutions for a full range of hernia repairs and abdominal wall reconstructions, including the most complex cases. Traditionally, large abdominal wall hernias can present a technical challenge for some surgeons. Our devices are now positioned to ensure that patients who are most at need have access to the most advanced technology to assist with their hernia repair,” Tela Bio prez &CEO Antony Koblish said in a prepared statement. “The ability to cover a larger surface area could have many potential benefits for patients and surgeons in terms of securing the most complex hernia repairs properly and reducing the risk of recurrence. As a joint developer and the manufacturer of the Ovitex technology, it is encouraging to see growing demand and the continued expansion of our product portfolio. We provide a robust and c...
Source: Mass Device - Category: Medical Devices Authors: Tags: Featured Food & Drug Administration (FDA) Regenerative Medicine Regulatory/Compliance aroabiosurgery Tela Bio Source Type: news

Related Links:

ConclusionsDue to our findings we assume that the AB may induce immobility and reduce postoperative pain. A prolonged period of physical rest and wearing an AB does not seem to have an impact on the postoperative outcome following IHR. Therefore, a shortened duration of physical rest and wearing an AB following IHR should be taken under consideration. To reveal more evidence on this topic further clinical trials are essential.
Source: Annals of Medicine and Surgery - Category: General Medicine Source Type: research
ConclusionThe use of self-gripping mesh with ACS can be performed without increasing the operative time or causing short-term surgical complications. This technique may be recommended for large IH because of its simplicity and secure abdominal reinforcement provided.
Source: International Journal of Surgery Case Reports - Category: Surgery Source Type: research
Conclusions: In small epigastric and small umbilical hernia repair a flat polypropylene mesh repair was associated with a lower complication rate than PVP repair. No differences in recurrence rates were seen. Combining all complications, the preperitoneal positioned flat polypropylene mesh performed better.
Source: Annals of Surgery - Category: Surgery Tags: RANDOMIZED CONTROLLED TRIALS Source Type: research
ConclusionsLike in other surgeries, ERPs were feasible and probably efficient to improve the post-operative course of incisional hernia patients. But the level of evidence remains low.
Source: Hernia - Category: Sports Medicine Source Type: research
Conclusions: All patients had successful abdominal wall closure. Most of the patients had minimal scar of the large hernia repair and the umbilicus was normal looking and well accepted cosmetically.
Source: Journal of Indian Association of Pediatric Surgeons - Category: Surgery Authors: Source Type: research
AbstractOpen inguinal hernia repair remains the most universal, ubiquitous, reliable, and cost-effective method of addressing the global burden of groin hernias. Advances in anatomic understanding and technique have refined a few well-established techniques that can address the majority of the burden of disease with low rates of morbidity, recurrence, and chronic pain. Prosthetic reinforcement has become routine because of the clear reduction in recurrence rates in general practice conferred by mesh and the less-appreciated consideration of simplification of the repair whereby operator variability, hernia type, anatomic va...
Source: Hernia - Category: Sports Medicine Source Type: research
Conclusion: Modified placement of composite mesh is safe and helps in minimising mesh-related complications of the Sugarbaker technique for parastomal hernias.
Source: Journal of Minimal Access Surgery - Category: Surgery Authors: Source Type: research
ConclusionThis meta-analysis and trial sequential analysis report no difference in recurrence rates between laparoscopic and open primary unilateral inguinal hernia repairs. Rates of acute and chronic pain are significantly less in the laparoscopic group.
Source: Hernia - Category: Sports Medicine Source Type: research
ConclusionCurrently, non-randomised interventional studies of VH repair are methodologically poor. Clear outcome definitions and a standardised minimum dataset are needed.
Source: Hernia - Category: Sports Medicine Source Type: research
ConclusionIn spite of resource limitations, the use of mesh for hernia repairs continues to rise and has overtaken tissue-based repairs in a sub-Saharan African setting. Results show good outcomes justifying continued use.
Source: Hernia - Category: Sports Medicine Source Type: research
More News: Gastroschisis Repair | Hernia | Hernia Repair