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Current Issues in Spine

February 2-4, 2017

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November 23, 2022 OrthoSpineNews

February 01, 2017

CHICAGO–(BUSINESS WIRE)–Family-owned orthopedics leader Medacta International is heading into 2017 with significant momentum in its U.S. spine business, including the appointment of a new Medical Director following breakout business performance in 2016. Effective immediately, noted spinal surgeon and data scientist S. Raymond Golish, MD, PhD, MBA will serve as Medical Director of the Medacta USA Spine Division. Dr. Golish will support Medacta’s U.S. subsidiary in its spine product development and commercial activities, helping the company expand upon its culture of collaboration, clinical excellence, and evidence-based and patient-centric innovation.

Dr. Golish is a fellowship-trained spinal surgeon, medical device and data scientist, and experienced healthcare administrator and executive. He currently acts as Medical Director of Spinal Surgery and of Clinical Trials at Jupiter Medical Center (Jupiter, Florida) and is a practicing spinal surgeon at Florida Spine Center in Palm Beach, Florida. He serves as Chairman of the American Academy of Orthopaedic Surgeons (AAOS) Biomedical Engineering Committee and Chairman and Director of the Board for the Research Committee of the North American Spine Foundation. From 2012 to 2016, he was a voting member on the U.S. Food and Drug Administration’s Orthopaedic and Rehabilitation Devices Panel. Dr. Golish received his PhD and MD from the University of California, Los Angeles in 2002 and 2004, respectively. He completed his spinal surgery fellowship at Stanford University in 2010 and received his MBA from Duke University in 2013.

“With his diverse experience as a surgeon, medical data scientist and expert in U.S. regulatory affairs, Dr. Golish will be an important addition to the Medacta spine team as it continues to introduce methodical, thoughtful and evidence-based innovations,” said Francesco Siccardi, Executive Vice President of Medacta International. “His steadfast dedication to patient safety and the role that medical device innovation can play in improving life aligns well with our ideals at Medacta, and we are thrilled to have him on board as we look to meet our ambitious growth targets in the year ahead.”

Dr. Golish joins Medacta following an impactful year. The company’s Spine Division experienced more than 140 percent sales growth in 2016 and now boasts five consecutive quarters of 24 percent quarter-over-quarter growth. Last year, the Division increased its customer base by 105 percent and added more than 40 new field agents selling its products in the U.S.

“Medacta’s key differentiator is its unique corporate culture, which focuses on excellence in patient care, quality, evidence and innovation in a way that moves the field forward while keeping safety paramount,” said Dr. Golish. “It’s an exciting time for Medacta as a whole, but especially for its Spine Division, which experienced transformative growth in 2016 and is poised to meet or even exceed upon the bold growth targets set for 2017.”

In 2016, Medacta’s Spine Division unveiled three new products, including the MySpine Low Profile Guide. Dr. Golish was one of the first U.S.-based surgeons to utilize the 3D-printed pedicle screw guide following its FDA clearance in October 2016. The pedicle screw guide builds on the MySpine Standard Profile, named by Orthopedics This Week as a Best New Technology for Spine Care when it was released in 2014.

About Medacta

Medacta® International is a world leading manufacturer of orthopedic implants, neurosurgical systems, and instrumentation. Medacta’s revolutionary approach and responsible innovation have resulted in standard of care breakthroughs in hip replacement with the AMIS®system and total knee replacement with MyKnee® patient matched technology. Over the last 10 years, Medacta has grown dramatically by taking a different approach and placing value on all aspects of the care experience from design to training to sustainability. Medacta is headquartered in Castel San Pietro, Switzerland, and operates in over 30 countries. To learn more about Medacta International, please visit www.medacta.com or follow @Medacta on Twitter.

Contacts

for Medacta USA
Jill Bongiorni, 516-729-2250
Jill@torchcomllc.com


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November 16, 2022 OrthoSpineNews

KILKENNY, Ireland, Nov. 16, 2022 /OrthoSpineNews/ — Spinal Stabilization Technologies (SST) has announced the start of the LOPAIN2 clinical trial of the PerQdisc™ Nucleus Replacement Device (NRD).

SST’s PerQdisc Nucleus Replacement Device will be studied in patients with degenerative disc disease (DDD) of the lumbar spine, which causes severe back pain, in patients without stenosis or instability. The PerQdisc is used for surgical replacement of a single nucleus pulposus between spinal lumbar discs L1-S1 using an anterior or lateral transpsoas approach. Currently, there is no good surgical option for these patients. SST’s PerQdisc NRD aims to treat discogenic low back pain while maintaining disc height and preserving range of motion.

This trial is enrolling 72 patients and taking place in seven research centers in South America. Data from the LOPAIN2 trials will be used to file for the CE Mark under the Medical Device Regulation (MDR) in Europe. The LOPAIN2 trial is registered on clinicaltrials.gov (NCT05508360).

“We’re impressed with the quality of clinical trial research in the South American region,” said Mark Novotny, CEO of SST. “These are advanced research centers with fully staffed research teams. The patient care and follow-up are excellent. In an earlier trial, no patient was lost to follow-up. The surgeons and their research staff we are working with are all highly trained in clinical research and motivated to make our trials in South America a success.”

Dr. Javier Duarte, principal, investigator at Hospital Americano in Asuncion Paraguay, the largest enroller in the overall SST clinical trial program, stated, “The results I’m getting with the PerQdisc are excellent. I have been able to refine the technique to a point where I’m comfortable routinely offering the option to my DDD patients.”

“I believe nucleus replacement is finally here to stay. I enrolled and treated the first patient in LOPAIN2. The procedure is easy to learn, and the result is a custom implant that is fitted perfectly to the patient’s anatomy,” added Dr. Rodolfo Paez, principal investigator at Hospital de San José in Bogota, Colombia.

SST will attend numerous meetings in 2023 to present the clinical data from its programs and present the technique to surgeons worldwide.

About Spinal Stabilization Technologies, Ltd
Spinal Stabilization Technologies, Ltd (SST), an Irish company headquartered in Kilkenny, Ireland, develops novel technologies for treating patients with lumbar discogenic back pain. SST’s products and techniques are based on the philosophy that less invasive surgery may be associated with better clinical outcomes and could improve the lives of many patients with limited options for treating their back pain. The company has extensive worldwide intellectual property and is focused on evidence-based medicine.

For more information, physicians may visit https://www.sstspine.com/

MEDIA CONTACT: Paul Maccabee, 612-366-5287


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November 9, 2022 OrthoSpineNews

August 4, 2016

The National Capital Consortium for Pediatric Device Innovation (NCC-PDI) is now accepting proposals for medical devices that address a significant, yet unmet pediatric need. This year, up to six innovations will be awarded up to $50,000 each during the “Make Your Medical Device Pitch for Kids!” competition on Saturday, Oct. 8, 2016 at the nation’s leading pediatric innovation symposium hosted by the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National Health System.

The FDA-funded consortium, led by the Sheikh Zayed Institute for Pediatric Surgical Innovation and the A. James Clark School of Engineering at the University of Maryland, invites proposals from innovators—researchers, entrepreneurs, and clinicians—with a pediatric medical device concept that lends itself to commercialization. In addition to the prize money, winners will receive consultation services from NCC-PDI. (For competition details, click here.)

“This year, we are combining our annual FDA-funded consortium pitch competition with our Institute’s annual symposium to bring greater attention to promising devices and give competition participants more exposure to investors, policy makers and children’s hospital executives that evaluate pediatric innovations,” said Kolaleh Eskandanian, PhD, Executive Director of the Sheikh Zayed Institute for Pediatric Surgical Innovation and NCC-PDI. “Our goal is to bring needed devices to children faster and to focus greater attention to helping bridge the gap that often follows the prototyping phase in the device development life cycle.”

Competition finalists will pitch their medical device to a distinguished panel of judges at the Sheikh Zayed Institute’s fourth annual Pediatric Surgical Innovation Symposium, “Helping Kids and the Economy Grow Stronger Through Innovation,” at the Marriott Wardman Park in Washington, DC. The one-day conference will bring together innovators, local economic development strategists, investors, patient advocates, and policy makers to stimulate pediatric device innovation and bring solutions to market faster.

See more at: http://www.mpo-mag.com/contents/view_breaking-news/2016-08-04/250k-pediatric-device-competition-now-accepting-proposals/#sthash.I60rKJWh.dpuf

For symposium agenda and registration, visit www.pediatric-surgery-symposium.org

 


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November 3, 2022 OrthoSpineNews

RANCHO SANTA MARGARITA, Calif.–(Business Wire)–Integrated Endoscopy, Inc. will demonstrate its nuvis™ Single-Use Arthroscope—the only single-use rigid endoscope commercially available in the United States—at the 2015 American Academy of Orthopaedic Surgeons (AAOS) Annual Meeting, March 25–27, 2015, in Las Vegas (booth No. 674).

The launch of the nuvis Single-Use Arthroscope comes at a time of heightened awareness about serious patient safety issues connected with endoscopic procedures, including a number of recent high-profile infection outbreaks caused by bacteria build up in difficult-to-clean endoscopes.

“We’re excited to introduce the nuvis Single-Use Arthroscope to orthopedic surgeons,” said George Wright, president and CEO of Integrated Endoscopy. “Our discussions with orthopedic surgeons across the country underscore the importance of exceptional optical quality in a disposable endoscope. The nuvis Arthroscope is the first single-use rigid endoscope based on 21st century optical technology. Its excellent optics and improved safety provide first-time quality for every procedure, benefiting surgeons and patients alike.”

READ MORE HERE