Bioretec Reports FDA Grants Breakthrough Device Designation for Bioresorbable RemeOs™ Screw products

Bioretec has received Breakthrough Device Designation for its bioresorbable RemeOs™ Screws from the US Food and Drug Administration, confirming that the product represents a breakthrough technology in traumatology and orthopedic surgery. Only a few companies in the field of medical devices have been granted with Breakthrough Device Designation in Finland.

Bioretec’s bioresorbable RemeOs™ Screws met the strict criteria set for FDA’s breakthrough technology. FDA requires breakthrough technology to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating conditions or diseases. In addition, breakthrough technology must either represent a completely new form of treatment or offer significant advantages over existing approved or cleared alternatives, including the potential to reduce the need for hospitalization, improve patients’ quality of life and create long-term clinical benefit, or alternatively represent a form of treatment that is in the best interest of patients.

Under the Breakthrough Devices Program, FDA will enable an ongoing and prioritized interactive discussion between Bioretec and the authorities regarding the commercial access of RemeOs™ Screws in the U.S. market.

“The approval of the RemeOs™ Screw products for the U.S. FDA’s Breakthrough Devices Program is a significant step for Bioretec in our efforts to commercialize the product in the United States. We are excited about this possible future opportunity for us to be able to offer patients and the healthcare system in the United States, a new, fully bioresorbable metal implant that will provide more effective care and improves the patient’s quality of life.Orthopedic surgeons would finally have access to a bioresorbable implant that follows current surgical techniques, and surgeons will not have to change or learn new procedures in surgeries,” says Timo Lehtonen, CEO of Bioretec.

Bioretec’s RemeOs™ Screw products are intended for use in traumatology and orthopedic surgery for the fixation of bone fractures and for the correction of deformities or malalignments.

The implant forms a temporary support for the fractured bone to ensure safe healing and allow the bone to reach its normal strength as the implant resorbs from the body. The bioactive properties of the implant and its natural degradation products assist in the development of new bone during the healing of the fracture.

The advantage of bioresorbable metal implants is that separate implant removal surgery is not required as the implants naturally resorb within the body after the fracture site ossifies. This shortens the recovery time and reduces potential adverse effects, thus also contributing to reducing the costs to the healthcare system. RemeOs™ Screws are made of a bioactive alloy that contains essential elements for new bone formation: magnesium, zinc and calcium. Implants consist only of materials that are naturally present in the human body.

SourceBioretec
Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine provides breaking medical device / biotechnology news. Our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

More News!

The Evolut ™ FX+ TAVR system leverages market-leading valve performance with addition of larger windows to facilitate coronary access
The study was an analysis of AstraZeneca’s Phase 2 52-Week clinical trial of tralokinumab in patients with Idiopathic Pulmonary Fibrosis (IPF). The patient data from the trial was processed with Brainomix’s e-Lung tool. The tool is uniquely powered by the weighted reticulovascular score (WRVS), a novel biomarker that incorporates reticular opacities and vascular structures of the lung.
“Since the algorithm for matching patients with donors is changing across for all organs, this was a prime time to better understand whether transplant team decisions to accept a donated organ varied by patient race and gender,” she said. “We wanted to understand how the process of receiving a transplant after listing varied by race and gender, and the combination of the two, so that steps can be taken to make that process more equitable," said Khadijah Breathett, MD.
The Mount Sinai study found that primary care physicians’ approach reflects a dearth of evidence-based guidance for lung cancer screening shared decision-making in patients with complex comorbidities
This is the first ever transplantation of a genetically engineered porcine kidney into a living human recipient.

By using this website you agree to accept Medical Device News Magazine Privacy Policy

Exit mobile version