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Beskrivning
| Land | Sverige |
|---|---|
| Lista | First North Stockholm |
| Sektor | Hälsovård |
| Industri | Medicinteknik |
Mölndal, Sweden, March 18, 2025 - Integrum AB (publ) (Nasdaq First North Growth Market: INTEG B) announces today that a newly published independent study from the Walter Reed National Military Medical Center in Bethesda, Maryland, U.S., provides compelling evidence of OPRATM Implant System's treatment effectiveness in transfemoral amputees. The study demonstrates significant functional improvements over traditional socket prostheses, an important validation of Integrum's innovative technology and its clinical benefit in patients who have undergone amputation.
The two-year follow-up study (Level II Evidence) includes the latest and most advanced version of the OPRATM Implant System, which was introduced in 2017. The study results highlight several key benefits for patients using the implant system, including increased prosthetic use, improved mobility, and enhanced quality of life. Importantly, the study reveals improved outcomes compared to previously published data, including fewer infections and complications, and a 100% implant survival rate.
"This study confirms the safety, durability, and positive impact of the OPRA Implant System for individuals who have undergone amputation. We are honored to support the men and women who have served their country and are excited to see growing evidence supporting its role in improving mobility and overall well-being for amputees globally," comments Scott Flora, acting CEO of Integrum.
Collectively, the insights gathered from this study will be useful in driving further adoption of the technology by US health providers, as well as to increase the awareness of the OPRATM Implant System among health professionals and potential patients.
"We need high quality prospective clinical trials like this to confirm not only the benefits of transdermal bone anchored implants, but also the complication profile over the long-term. By further proving safety and effectiveness of The OPRA Implant System, we hope this growing body of evidence will encourage exponential acceptance among US insurance providers for reimbursement, making this life-changing technology more accessible to patients in need," Dr. Jonathan Forsberg, MD, PhD currently practicing at Memorial Sloan Kettering in New York, retired from the military after 32 years of service.
"We were excited to see that our results further confirmed the benefits of direct skeletal attachment for improving function and quality of life for patient with limb loss, while maintaining better than expected infection and major complication rates," says Dr. Benjamin K. Potter, MD, currently Chair, Department of Orthopaedic Surgery at Penn Medicine in Philadelphia, PA. Dr. Potter retired from the Army after over 22 years of service.
The study was authored by Benjamin K. Potter, MD, Jonathan A. Forsberg, MD, PhD, LCDR Ashley B. Anderson, MD, Jason M. Souza, MD, and Julio Rivera, PhD, and recently published in Clinical Orthopaedics and Related Research (CORR).
Read the full article: https://journals.lww.com/clinorthop/abstract/2025/03000/what_functional_outcomes_can_be_expected_with.24.aspx.