TransEnterix wins FDA nod for 3mm instrument set

TransEnterix (NYSE:TRXC) said today that it won 510(k) clearance from the FDA for a 3mm-diameter instrument set for its Senhance robot-assisted surgery device. The federal safety watchdog also OK’d additional 5mm-diameter instruments, the Research Triangle Park, N.C.-based company said. The 3mm instrument open up micro-laparoscopic “virtually scarless” procedures for Senhance, according to TransEnterix. “The ability to perform microlaparoscopic procedures using 3-millimeter instruments represents an unparalleled shift in the world of robotic surgery and a capability exclusive to the Senhance system,” CEO Todd Pope said in prepared remarks. “The addition of 3-millimeter instruments will allow many high volume surgeries to be performed with smaller incisions, which supports our mission of advancing minimally invasive surgical capabilities within digital laparoscopy.” “Utilizing 3 millimeter micro instruments on a robotic system represents a new advancement in reducing the invasiveness of many surgeries,” added Dr. Steven McCarus of Florida Hospital Celebration Health. “Patients find such small incisions to be virtually scarless and cosmetically desirable. Surgeons may find that using such tiny instruments with the precision and control of a digital interface makes microlaparoscopy a preferred option to treat more conditions.” Earlier this month TransEnterix won CE Mark approval in the European Union for...
Source: Mass Device - Category: Medical Devices Authors: Tags: Featured Food & Drug Administration (FDA) Regulatory/Compliance Robotics Surgical TransEnterix Source Type: news

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Conclusions: This study shows promising trends toward an advantage of PAIR procedures in treatment of liver hydatid cyst in comparison with laparoscopic procedures. The PAIR procedure is superior to laparoscopy due to having a higher cure rate and lower complication and mortality rates; however, the latter has a lower recurrence rate. PMID: 30899281 [PubMed]
Source: Archives of Medical Science - Category: General Medicine Tags: Arch Med Sci Source Type: research
ConclusionsThe amount of intraoperative guidance is influenced by many factors, including resident performance and case characteristics. FLS tasks performance was not significantly associated with intraoperative guidance.
Source: The American Journal of Surgery - Category: Surgery Source Type: research
Discussion: Incomplete septal cirrhosis is an uncommon cause of non-cirrhotic portal hypertension. Its definition is not well known, morphological and pathophysiological. We have not found published cases of post-RT ascites secondary to this pathology, described as possibly associated with drugs, immune alterations, infections, hypercoagulability and genetic predisposition. PMID: 30897191 [PubMed - as supplied by publisher]
Source: Jornal Brasileiro de Nefrologia - Category: Urology & Nephrology Tags: J Bras Nefrol Source Type: research
CONCLUSIONS: Abdominal pain after gastric bypass is a frequent cause of admission to the emergency department. Besides the more serious complications, internal hernia is often withheld as possible diagnosis in the differential diagnosis of late onset, postprandial epigastric pain. This case report highlights another possibility. At initial surgery, a candy cane shaped blind loop should be avoided both at the gastro-jejunal as well as the entero-enteric anastomosis. PMID: 30900521 [PubMed - as supplied by publisher]
Source: Acta Chirurgica Belgica - Category: Surgery Tags: Acta Chir Belg Source Type: research
CONCLUSION: The presented case confirms the importance of interdisciplinary cooperation between surgeons, gynaecologists, and pathologists. We also want to emphasize the need for extensive pathological examination of the resected specimens which is essential for a proper diagnosis. KEY WORDS: Endometriosis, Rectum, Spontaneous perforation. PMID: 30898991 [PubMed - in process]
Source: Annali Italiani di Chirurgia - Category: Surgery Tags: Ann Ital Chir Source Type: research
Authors: Petzold T PMID: 30898029 [PubMed - as supplied by publisher]
Source: Journal of Investigative Surgery - Category: Surgery Tags: J Invest Surg Source Type: research
CONCLUSIONS: Laparoscopic surgery should not be considered a contraindication in patients with COPD. Careful consideration of surgical technique can have significant implications on patient outcomes and hospital costs in the COPD population. PMID: 30897984 [PubMed - as supplied by publisher]
Source: Journal of Investigative Surgery - Category: Surgery Tags: J Invest Surg Source Type: research
CONCLUSION: Our future plan is to investigate the cost and effectiveness of the curriculum and to reveal if practice and repetition will lead to mastering 3D skills among novices (medical students and junior doctors). PMID: 30897977 [PubMed - as supplied by publisher]
Source: Journal of Investigative Surgery - Category: Surgery Tags: J Invest Surg Source Type: research
ConclusionBowel perforation in the elderly, presenting with cachexia and treatment-induced pancytopenia for advanced ovarian cancer, is often a harbinger of early death. Selected patients may benefit from a minimally invasive approach by an experienced gynecologic oncologist instead of vertical laparotomy, abdominal washout, diversion and the potential sequelae of an open abdomen.
Source: Gynecologic Oncology Reports - Category: OBGYN Source Type: research
We present two cases of RALP in LTRs with localized prostate cancer (PCa). In both cases, a transperitoneal approach was used, and they were successfully completed without perioperative complications. Thus, RALP seems to be a feasible, safe and effective treatment for PCa in LTRs. Significant modifications to the surgical technique do not seem to be required, and patient optimization in preparation for surgery remains the key factor. History of liver transplant should not discourage embarking in a RALP in Centers with adequate robotic expertise. PMID: 30895766 [PubMed - as supplied by publisher]
Source: Minerva Urologica e Nefrologica - Category: Urology & Nephrology Tags: Minerva Urol Nefrol Source Type: research
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