HSS and Rothman Institute/Jefferson University Hospital to Participate in Clinical Trial for Elute’s Antibiotic Loaded Bone Void Filler
December 6, 2021
Following Elute, Inc.’s Investigational Device Exemption (IDE) authorization from the US Food and Drug Administration (FDA) to use its EP Granules with Tobramycin™ in a pivotal clinical trial, the Hospital for Special Surgery (HSS), and the Rothman Orthopaedic Institute (Rothman) have agreed to become clinical sites to evaluate the safety and efficacy of the EP Granules. This addition of HSS and Rothman as clinical partners demonstrates the interest in exploring additional treatment options for difficult to treat periprosthetic joint infections, and expands the number of sites, facilitating patient enrollment. HSS and Rothman will join a group of Elute’s clinical partners focused on improving patient care and driving clinical value.
“I’m pleased to be a part of the clinical collaboration and help evaluate new technologies and products that have the potential to improve outcomes for our patients today. A product that is designed to address infection burden in total joint surgery is worth investigating,” said Amar Ranawat, a leading orthopaedic surgeon at HSS who has focused much of his practice on hip and knee replacement, researching major advancements in technique and technology. He is Professor of Clinical Orthopaedic Surgery at Weill Cornell Medical College and an attending orthopaedic surgeon at HSS and New York Presbyterian Hospital.
“Rothman/Jefferson is happy to participate in this important clinical trial that will evaluate the role of an important and innovative product that offers the potential to help patients. As a clinician and researcher in the field of orthopedic infections, I am excited about the promise of this technology,” said Dr. Javad Parvizi”, a Board Certified, fellowship trained, orthopaedic surgeon and the Director of Clinical Research at Rothman, and the James Edwards Professor Chair of Orthopaedics at Thomas Jefferson University. He specializes in the management of patients with complex hip and knee conditions. He is a renowned world expert in the field of periprosthetic joint infection, joint preservation, and joint reconstruction. He has performed over 10,000 joint procedures including over 1,100 preservation surgeries. Dr. Parvizi travels extensively across the world to give lectures related to his area of expertise. He has served as the president of Musculoskeletal Infection Society (2013), Eastern Orthopedic Association (2018) and serves on the board of numerous organizations and societies. He will be the president of American Association of Hip and Knee Surgeons in 2023.
“We are pleased to welcome Drs Ranawat and Parvizi to our list of clinical partners. These are renowned and trusted leaders in advancing musculoskeletal knowledge and research for physicians, nurses, allied health professionals, academic trainees, and consumers in more than 130 countries” said Ashok Khandkar, PhD, CEO of Elute, Inc. “We’re honored to have them as collaborators for our FDA authorized pivotal, randomized, blinded, prospectively controlled IDE clinical evaluation as we work to advance the development of novel solutions that address unmet needs in treating bone infections.”
Contact Information:
Ashok Khandkar, Ph.D., President and CEO
Elute, Inc.
(801) 505-0630
324575@email4pr.com
SOURCE Elute, Inc.