BG Klinik Tübingen, among the first in Germany to treat thumb amputees with Integrum’s OPRA[™]Implant System
On January 27th, the Department of Hand, Plastic, Reconstructive and Burn Surgery of the BG Trauma Center in Tübingen treated its first patients with the OPRA™ Implant System, and became one of the first hospitals in Germany to utilize the technology in the treatment of thumb amputees.
The department is an integral part of the BG Trauma Center and the Eberhard Karls University Tübingen. One of its main foci of treatment is the functional reconstruction of extremities. In the clinic, the specialists develop an individual treatment concept for each patient, and accompany them through the full rehabilitation process; from the accident itself, to the patient’s return to a normal, active, everyday life. While BG hospitals are medical facilities of the statutory accident insurance (Berufsgenossenschaft), they are open to all patients, regardless of their health insurance scheme.
PD Dr. Jonas Kolbenschlag, Leading Senior Physician at the Plastic Surgery Unit, who is spearheading Tübingen’s osseointegration program, was joined by Professor Brånemark in the treatment of a transhumeral amputee, and a thumb amputee, who became one of the first patients in Germany to receive the OPRATM Implant System for this indication. These two surgeries marked the start of Integrum’s comprehensive training and certification process of this new member of the OPRATM network.
Says Dr. Kolbenschlag “Osseointegration enables us to provide the optimal solution for prosthetic rehabilitation in select patients. We are proud to be among the few hospitals in Germany to offer this advanced treatment and will continue to further expand our ossointegration program.”
Maria Lopez, CEO at Integrum, shared her thoughts on this milestone: “Germany is the third largest market for medical devices in the world, and is therefore very important to us. We are therefore very pleased and proud to welcome Tübingen into the growing number of German medical facilities and institutions using the OPRA™ Implant System for several treatment indications”.
About the OPRA™ Implant System – Thumb Replacement
The OPRA™ Implant System is a bone-anchored system based on osseointegration, where the prostheses are directly attached to the bone; thus avoiding the use of a socket. The system utilizes a modular design consisting of three main parts, that have been developed and refined based on many years of development and clinical research. The unique modular design ensures protection of the patient by avoiding bone fractures from accidental or unfavorable loading. The implant components are inserted surgically into the bone of the amputation stump in one or two surgical procedures.
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Fixture: Anchoring element inserted into the patient’s bone
- Abutment: Skin penetrating connection attached to the fixture
- Abutment Screw: A screw made of titanium alloy that locks the Abutment to the Fixture
While products within the OPRA™ Implant System thumb assortment are CE marked and available in Europe, they are not yet commercially available in the US.
This disclosure contains information that Integrum AB is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person, on 23-02-2021 10:00 CET. Integrum is listed on Nasdaq First North in Stockholm. Erik Penser is the Company's Certified Adviser.
For further information, please contact:
Maria Lopez, CEO
Cell. +46 (0) 708-46 10 69
Email: maria.lopez@integrum.se
Certified Adviser:
Erik Penser Bank AB
Tel. +46 (0) 8 463 8000
Email: certifiedadviser@penser.se
About Integrum
Integrum AB is a publicly-traded company (INTEG B: Nasdaq First North exchange) based outside of Gothenburg, Sweden, with a US subsidiary in San Francisco, CA. Since 1990 osseointegration, the science behind the OPRA™ Implant System has been helping individuals with amputations towards an improved quality of life. Thorough surgical experience gained over almost three decades from 500 surgeries in 14 countries has led to the development of Integrum’s system for bone-anchored prosthetics – a beneficial alternative to the traditionally used socket prosthesis. Integrum’s OPRA™ Implant System was approved by the US Food and Drug Administration (FDA) in 2015 for use in the US under a Humanitarian Use Device (HUD) designation, which was reviewed through the Humanitarian Device Exemption (HDE) pathway, which limited the level of marketing and sales activities. In December 2020, Integrum successfully completed the most stringent medical device regulatory procedure in the world, and based on the solid scientific data submitted, was granted a PMA by the FDA for the OPRATM Implant System, which is the only technology approved for above knee, bone-anchored prosthetics in the U.S. More information on the company and its innovative solutions for amputees can be found at www.integrum.se.
