(Reuters) — For heart disease patients who adhere to optimal medical therapy, outcomes of coronary bypass graft surgery and percutaneous coronary intervention may not differ, a new study finds. However, among non-adherent patients, CABG affords better major adverse cardiac event-free survival. When they don’t take their meds as directed, CABG patients are 68% more likely […]
Surgical
Spineology wins FDA 510(k) for Rampart Duo interbody fusion device
Spinal tech developer Spineology said today it won FDA 510(k) clearance for its Rampart Duo interbody fusion system. The St. Paul, Minn.-based company said its newly-cleared Rampart Duo is the 1st device of its kind to combine PEEK, titanium and graft containment mesh elements. “Rampart Duo is an innovative interbody fusion device that builds upon Spineology’s OptiMesh […]
Johnson & Johnson’s Ethicon wins FDA nod for expanded Evarrest indication
Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon said today it won an expanded indication from the FDA for its Evarrest fibrin sealant patch, now cleared for use as an adjunctive hemostat across a “broad range” of challenging patient types and surgical situations. The company touted the win as a significant milestone in controlling problematic bleeding situations “with high confidence.” “I’m […]
Second Sight reveals 1st implant of Orion I visual cortical stimulator
Second Sight Medical (NSDQ:EYES) said today the 1st patient was implanted with its Orion 1 visual cortical prosthesis device designed to restore vision to blind patients. The procedure was performed as part of a proof-of-concept trial at UCLA. The trial looks to show initial safety and feasibility for human visual cortex stimulation, Sylmar, Calif.-based Second Sight said. […]
In-utero heart surgery patient is now 3 and healthy
At just 24 weeks of gestation, Tucker Roussin underwent fetal surgery at the Children’s Hospital of Philadelphia to treat a life-threatening tumor connected to his heart. Now, he is a healthy 3-year-old preschooler, the hospital reported today. Intrapericardial teratoma is a rare, rapidly growing tumor that can be detected while the child is in utero. […]
FDA clears pediatric spine implants from Medicrea
Medicrea (EPA:ALMED) said today it won FDA 510(k) clearances for is Pass XS posterior fixation and LigaPass XS band connector components designed for pediatric spinal deformities in small stature patients. The New York City and Lyon, France-based company said it worked with a team of pediatric spinal surgeons to develop the low profile implants specifically designed […]
Stealthy medtech VR-dev Vicarious Surgical raises $800,000
Stealthy Vicarious Surgical raised $800,000 in a new round of equity financing, according to an SEC filing posted yesterday. The funds bring the total raised for the company up to $3.2 million, topping off a $2.4 million round it reported in February of this year. All of the money in the round came from 1 […]
JNJ’s Ethicon launches Harmonic HD 1000i surgical shears
Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon said today it launched its high-precision Harmonic HD 1000i surgical shears, which are designed for procedures involving complex thoracic, hepato-pancreato-billary, colorectal and gynecologic oncology. The Cincinnati-based company’s touted the device’s dissection, transection, and sealing capabilities as being able to replace a number of other devices used in open and laparoscopic surgery. The […]
Orthocell wins ethics nod for CelGro trial in peripheral nerve regeneration
Orthocell (ASX:OCC) said today that it won ethics approval for a human study evaluating its CelGro collagen soft tissue repair device for peripheral nerve regeneration. The study is slated to enroll 20 patients at St. John of God Hospital at the end of the calendar year. Researchers will evaluate the safety, tolerability, and effectiveness of CelGro […]
Boston Scientific launches Resolution 360 hemostasis clip
Boston Scientific (NYSE:BSX) said today that it launched its Resolution 360 hemostasis clip, designed to provide physicians with controlled rotation for more accurate clip placement during endoscopy procedures. The Marlborough, Mass.-based company’s device uses a multi-wire catheter, which can rotate the clip in small, controlled movements to guide it to the targeted area. Physicians at the United European Gastroenterology […]
CDC warns on 3T heater-cooler from LivaNova’s Sorin
The U.S. Centers for Disease Control & Prevention yesterday warned of the risk of serious bacterial infection in open heart surgery patients patients from a device made by Sorin, which merged last year with Cyberonics to form LivaNova (NSDQ:LIVN). The 3T heater-cooler device is used to maintain patients’ blood and organs at a specific temperature. The CDC said the devices may have been contaminated […]