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

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AbstractBackgroundUtilization of robotic-assisted inguinal hernia repair (IHR) has increased in recent years, but randomized or prospective studies comparing outcomes and cost of laparoscopic and Robotic-IHR are still lacking. With conflicting results from only five retrospective series available in the literature comparing the two approaches, the question remains whether current robotic technology provides any added benefits to treat inguinal hernias. We aimed to compare perioperative outcomes and costs of Robotic-IHR versus laparoscopic totally extraperitoneal IHR (Laparoscopic –IHR).MethodsRetrospective analysis o...
Source: Surgical Endoscopy - Category: Surgery Source Type: research
ConclusionsPatients reported that times for resumption of outdoor walking, driving, and sexual activity were significantly longer than those recommended by surgeons. Age, BMI, bilateral repair, and recurrent hernias were found to be factors affecting return time to different activities.
Source: Hernia - Category: Sports Medicine Source Type: research
Source: Hernia - Category: Sports Medicine Source Type: research
ConclusionsIn this study, staged mesh repair of complex abdominal wall hernias after bariatric surgery in morbidly obese patients was associated with acceptable morbidity and no hernia recurrences at approximately 1.5  year follow-up.
Source: Hernia - Category: Sports Medicine Source Type: research
The goal of our study was to compare results in patients with large midline incisional hernia using modified anterior component separation versus preoperative botulinum toxin and following Rives repair, with a focus on surgical site occurrences, possibility of fascial closure, duration of hospital stay, and hernia recurrence rate.
Source: Surgery - Category: Surgery Authors: Source Type: research
ConclusionOur experience shows the importance of an overall view of the functional and cosmetic impairment created by DR. The surgeon should obtain an optimal repair of the function, by open or minimally invasive surgery, also considering the morphological aspects, which are very important for the patients in terms of QoL.
Source: Hernia - Category: Sports Medicine Source Type: research
The concept of single-port laparoscopic percutaneous extraperitoneal closure for the treatment of inguinal hernias repair in children has been practising recent years. The applicable instruments and skills are...
Source: BMC Surgery - Category: Surgery Authors: Tags: Research article Source Type: research
ConclusionThe use of the local hemostatic agent Haemoblock can reduce the duration of the postoperative wound draining, shorten the period of inflammatory exudative processes in the postoperative wound, significantly reduce the number of puncture interventions for the postoperative wound, reduce the risk of the seromas formation and surgical site infections (SSI) associated with seroma, reduce the severity of pain and the need for analgesics.
Source: Hernia - Category: Sports Medicine Source Type: research
CONCLUSIONS Laparoscopic and non-laparoscopic MIS surgery are feasible and safe for abdominal organ transplant patients and are helpful for timely intervention in cases with acute abdomen. No adjustment of immunosuppressant is usually needed, as oral intake can be resumed very soon after surgery. PMID: 32541640 [PubMed - in process]
Source: Annals of Transplantation - Category: Transplant Surgery Authors: Tags: Ann Transplant Source Type: research
ConclusionWatchful waiting may be an acceptable option for select patients with asymptomatic ventral hernias at the time of initial PD catheter placement. These findings highlight the need to better identify factors associated with asymptomatic ventral hernias that do not warrant concomitant repair to aid surgeons in the decision-making process.
Source: Hernia - Category: Sports Medicine Source Type: research
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