LivaNova (NSDQ:LIVN) today announced the 1st U.S. implantation of its Perceval sutureless aortic valve replacement. The implantation, which took place last week, was headed by Dr. Douglas Johnson and Dr. Eric Roselli at the Cleveland Clinic in Ohio, with the patient receiving 2 valves during the operation. “The availability of a sutureless valve optimizes surgical options to treat aortic […]
Surgical
J&J’s Ethicon touts Evarrest in study of aortic repair
Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon is touting a Phase III clinical study of its Evarrest fibrin sealant patch in surgeries to repair the aorta, saying the patch handily beat Baxter‘s (NYSE:BAX) competing TachoSil product. Ethicon said the 156-patient Evarrest CV trial showed that hemostasis was achieved within 3 minutes and maintained throughout the surgery for 75% of the Evarrest cohort, […]
Arch Therapeutics launches EU trial for AC5 hemostat
Arch Therapeutics (OTC:ARTH) said today that it launched a European safety-and-efficacy study of its AC5 surgical hemostat in bleeding wounds incurred during dermatology procedures. Framingham, Mass.-based Arch, which won approval for the randomized, controlled, single-blind study last December, said the 46-patient trial will include a 10-subject arm who are taking blood thinners. Each patient will have […]
FDA accepts HDE submission from InVivo for Neuro-Spinal scaffold
InVivo Therapeutics (NSDQ:NVIV) said today that the FDA accepted its proposed Humanitarian Device Exemption modular shell submission and review process for its Neuro-Spinal Scaffold. The modular HDE review process is based on individual sections that constitute a complete HDE submission when all have been submitted, and allows for separate review and more timely feedback to aid […]
Stryker launches interbody fusion device
Stryker (NYSE:SYK) today released the Aero-C cervical stability system and cervical interbody fusion device designed for anterior cervical discectomy and fusion procedures. The device was launched at the American Academy of Orthopaedic Surgeons annual meeting in Orlando, Fla. this week. The Aero-C is based on Allendale, N.J-based Stryker’s patented compression technology which features anchor fixation […]
Intuitive Surgical touts less complications in robot-assisted hysterectomy study
Intuitive Surgical (NSDQ:ISRG) today said that results from a study evaluating robotic-assisted hysterectomies were published in the International Journal of Gynecology and Obstetrics, indicating fewer complications in robot-assisted surgeries compared to conventional methods. The study reported that individuals who underwent the surgery with the Sunnyvale, Calif.-based company’s da Vinci robotic system experienced fewer intraoperative complications than patients […]
FDA warns of neurosurgical head clamp slippage
The FDA today released a safety communication warning about slippage associated with skull clamps moving before and during surgical procedures, with 700 reported injuries associated with such failures. The devices, neurosurgical head holder systems, are designed to secure the patient’s head during surgical procedures. The devices may include a head holder frame that attaches to an […]
Nico wins $15 million for BrainPath neurosurgery device
Nico Corp. said it raised $15 million of a hoped-for $18 million funding round, led by prior backers River Cities Capital Funds and the Rose-Hulman Institute of Technology, for its BrainPath neurosurgery device. Indianapolis-based Nico said in a regulatory filing that 41 investors participated in the round, which nearly doubled its previous fundraising efforts. The BrainPath […]
TransMedics launches pivotal trial for OCS liver transplant system
TransMedics said today that it launched a pivotal study of its OCS Liver device, which is designed to keep donated human liver warm and perfused until transplantation. Andover, Mass.-based TransMedics said the 1st liver transplantation using OCS Liver was performed at Mass. General Hospital by Dr. James Markmann, a lead investigator for the 300-patient OCS Liver […]
Stealthy Vicarious Surgical raises $2.4m
Stealthy Vicarious Surgical said it raised nearly $2.4 million for the surgical virtual reality software it’s said to be developing. Cambridge, Mass.-based Vicarious reported the equity offering, which involved 11 unnamed investors, in a regulatory filing yesterday. Details about Vicarious are scarce. The company’s 1-page website consists of a logo and email address; according to Bloomberg, the company develops […]
Stryker consolidation leads to 200-job expansion in Texas
Stryker (NYSE:SYK) is reportedly expanding its Stryker Communications operation in Texas as it consolidates other businesses in South Carolina and the Lone Star State. Kalamazoo, Mich.-based Stryker is expanding the communication business HQ in Flower Mound, Texas, to more than 200,000 square feet to accommodate some 200 new workers, the Dallas Business Journal reported. The […]