New additions to Miami line of orthopaedic technologies

Miami® TLSO Provides Advanced Compression and Immobilization for Thoracic and Lumbar Spinal Areas

FOOTHILL RANCH, CA., May 01, 2019 – Össur is introducing two new products to its signature Miami brand line of advanced orthopaedic supports: the Miami J® Select Cervical Collar for people who require gross immobilization of the cervical spine, including trauma victims and cervical spine surgery patients, and the Miami® TLSO advanced spinal compression support system for patients requiring gross spinal immobilization up to T7.

Drawing upon Össur’s decades of biomechanical design expertise and input from clinical experts, the new Miami J Select Cervical Collar features an universal intuitive design intended to provide optimal comfort and compliance for patients without compromising on requirements of immobilization, fit or performance. It is intended to provide optimal immobilization and comfort while minimizing pressure points and skin breakdown in key areas of contact, including the chin, occiput, trapezius and clavicle. Its patented design features the widest available range of height adjustability and first-to-market locking mechanism as well as Flex-Edge® technology on the back of the collar specifically designed to reduce occipital pressure. Together, these features encourage patient compliance by ensuring users do not tamper with clinically prescribed levels of collar height, particularly during post-op and rehab periods.

A proprietary, integrated Sternal-Relief Dial enables adjustments when a patient is chewing or sitting for added comfort. Blue is YouTM intuitive blue touch points on the Sternal-Relief Dial and straps simplify patient education and product use. In addition, clinicians may specify optional Reproducible Fit Tabs, which can make it easier for the patient to don or doff the Miami J Select according to physician instructions.

The Miami J Select also features proprietary anti-microbial Sorbatex™ padding, which helps limit excessive moisture and has been shown to inhibit microbial growth by over 99%1. Sorbatex has also demonstrated superior durability and quick-dry properties, drying over 30% faster than traditional cotton/foam padding2. The Miami J Select also features a large tracheal opening to accommodate the needs of ICU patients who may need tracheotomies, while simultaneously reducing the need for a separate tracheal extension piece.

During field tests, the Miami J Select was validated as providing easy height adjustability and donning and doffing3 through evaluations performed by trauma program managers, nurses and educators. In a biomechanical study on 22 healthy participants that compared Miami J Select to industry-leading universal and sized collar designs, subjects reported comfort and tissue-interface pressure (TIP) at the occiput, mandible and sternum that was comparable4 to Össur’s classic, clinically proven Miami J5. . In addition, the Miami J Select was found to replicate immobilization of the cervical spine compared to the same collars, in all planes of movement6.

The Miami J Select is reimbursable in the U.S., with PDAC approval for both the brace (L0174) as replacement padding as needed (L0999), and is now available throughout the U.S.

Miami TLSO: Intuitive, Modal Design for Optimal Patient Comfort and Immobilization

Össur’s new Miami TLSO brace is an easy-to-use, fully assembled support that provides gross immobilization of the thoracic and lumbar spine for a variety of patients, including those needing post-surgical immobilization, spinal support up to T7, or recovering from spinal stenosis, herniated disc, and degenerative spinal fractures. It is also indicated for patients with spondylolisthesis or spondylolysis.

The low profile, lightweight Miami TLSO is made of a durable, ventilated fabric and features Össur’s Blue is YouTM intuitive patient touch points and soft, comfortable shoulder straps. Its anatomically contoured design is intended to immobilize the spine while maximizing patient comfort, with high strength, ventilated rigid panels that can be heat molded, grounded or trimmed to suit the patient’s anatomy as needed.

The brace, designed to accommodate patients ranging in height from 5’1” to 6’5” and waist circumferences from 26-70 inches with belt extension option, requires minimal preparation and is designed to provide optimal patient comfort, whether applied in over-the-shoulder or underarm configurations. Donning and doffing are further simplified with conveniently located quick-release buckles.

The Miami TLSO brace is reimbursable in the U.S. and is now available throughout the country.

The comprehensive Össur Miami family covers the full spine spectrum from cervical spine to sacrum, built upon decades of experience in design and continuous input from clinical experts. Össur Spinal Solutions provide intended spine-immobilization with the best possible comfort and compliance, and simplified adjustability without compromising immobilization, fit or performance.

1. Under ISO 20743 testing
2. Data on file at Össur
3. Society of Trauma Nurses TraumaCon (March 2018). Clinical Opinion Leader Survey
4. Data on file at Össur
5. Tescher AN et al. (2016). Comparison of Cervical Range-of-Motion Restriction and Craniofacial Tissue-Interface Pressure With 2 Adjustable and 2 Standard Cervical Collars. Spine, 41(6): E304-12
6. Data on file at Össur