Fidest – Agenzia giornalistica/press agency

Quotidiano di informazione – Anno 32 n° 279

Posts Tagged ‘clearence’

Medacta Receives FDA Clearance for Anatomic and Reverse Shoulder Systems

Posted by fidest press agency su sabato, 28 ottobre 2017

chicagoChicago. Medacta International, developer of innovative surgical techniques and products for the hip, knee, spine, and sports medicine disciplines, recently expanded its expertise to the world of shoulder surgery. The family-owned orthopedics leader today announced it has received FDA clearance for the Anatomic Shoulder and Reverse Shoulder components of its modular Medacta Shoulder System. The company also announced the successful completion of the first surgery in the United States utilizing the system, which was performed by Matthew D. Saltzman, M.D., Associate Professor of Orthopaedic Surgery at the Northwestern Memorial Hospital in Chicago, Illinois.“The procedure went very well,” said Dr. Saltzman, who specializes in shoulder and elbow surgeries and has been practicing orthopedics for 14 years. “The Medacta Shoulder System’s instrumentation and implants allow for impressive anatomic restoration, resulting in an efficient surgery and, hopefully, improved patient outcomes.”The Medacta Shoulder System, unveiled in February 2017 following its first ever surgery in Europe, is a modular solution that features a broad range of options, including wide-ranging sizes, adjustable offset, and innovative configurations. Developed by an international team of expert surgeons, the platform offers the modularity and compatibility demanded by today’s marketplace, while still respecting anatomic conversion from primary to reverse.The Shoulder System is also supported by the Medacta Orthopaedic Research and Education (M.O.R.E.) Institute’s Clinical Excellence Program and is part of a multi-center, post-marketing, prospective, open clinical study that will collect clinical and radiological outcomes for the next ten years. The M.O.R.E. Institute provides continuous educational and developmental support to Medacta surgeons as they work towards discovering new technologies and supporting patients.“The new Medacta Shoulder System is a continuation of our effort to improve orthopedic implant design and configurability for the benefit of both surgeons and their patients,” said Francesco Siccardi, Executive Vice President of Medacta International. “This latest surgery in the United States marks a milestone for Medacta in line with our company’s patient-centric vision and the same ambition that has helped us become a leader in knee, hip, and spine technology.”Medacta will launch the Shoulder System for the U.S. market at the American Academy of Orthopaedic Surgeons Annual Meeting, which will be held in New Orleans in March 2018.

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FDA Cleared New Application for Simbionix PROcedure Rehearsal Studio

Posted by fidest press agency su sabato, 25 febbraio 2012

Cleveland (PRNewswire) Simbionix USA Corporation, the world’s leading provider of medical education and simulation training, is pleased to announce that Simbionix received FDA clearance for the EVAR (Endovascular Aneurysm Repair) application for the PROcedure Rehearsal Studio™ (PRS). Last year Simbionix received clearance for the PRS Carotid Intervention application. The PROcedure Rehearsal Studio transforms the patient’s CT scan into a 3D visualization model. Simbionix has developed a revolutionary technology to use this 3D visualization model within its endovascular simulator, the ANGIO Mentor, to allow surgeons to evaluate endovascular surgical treatment options before surgery. PRS provides a 3D model of the patient’s vasculature and true-to-life vessel measurement tools. After exporting the 3D model into the ANGIO Mentor simulator practice environment, the physician is able to train and practice aneurysm repair on the patient’s specific anatomy. For the first time, surgeons can practice endovascular abdominal aortic aneurysm repair, including precise deployment of the bifurcated and contralateral leg stent graft, deployment of iliac and aortic extensions and touch-up ballooning. According to Dr. Yael Friedman, Director of Regulatory Affairs for Simbionix, the Simbionix track record in advanced medical education and training is unmatched, with more than 140 studies documenting the effectiveness and value of Simbionix medical simulators. “Based on this foundation, and on quality control, development, and production processes that were put in place over the past few years, we are pleased to be able to move beyond training and also provide the market with a clinical tool,” Dr. Friedman said. “We are very proud that the FDA has cleared the EVAR application and continues to recognize the clinical component of the PROcedure Rehearsal Studio.”
Simbionix is the world’s leading provider of simulation, training and education products for medical professionals and the healthcare industry. The company is committed to delivering high quality products, advancing clinical performance and optimizing procedural outcomes. Visit: http://www.simbionix.com

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