First Patients For Integra’s New Shoulder Resurfacing Implant

In short

Integra LifeSciences Holdings Corporation has announced the first implantations of its PyroTITAN® Humeral Resurfacing Implant in patients in Milan, Italy and Stockholm, Sweden. The PyroTITAN® implant is used in shoulder resurfacing, a more conservative alternative to shoulder replacement surgery.

Background

Last year Integra acquired Texas company, Ascension Orthopaedics for a reported $65M in cash. This product was part of the package.

Shoulder arthroplasty procedures continue to grow in line with patient population, activity levels, and life expectancy. Humeral head joint resurfacing is a surgical procedure that allows patients to retain much of their natural tissue by replacing only the diseased part of the joint instead of the entire joint and the glenoid. It may allow for a smaller incision, less bone removal, and a shorter recovery.

Available in twelve sizes, the PyroTITAN® Humeral Resurfacing System is intended to address glenohumeral joint disease due to non-inflammatory, inflammatory and post traumatic arthritis by replacing the damaged humeral head bearing surface and restoring patient anatomy while preserving bone. This system provides size-specific, color-coded, cannulated instrumentation for ease of use and reproducibility. The PyroTITAN® Humeral Resurfacing implant is composed of PyroCarbon, a specific form of carbon with specially manufactured crystalline structures which the company claims gives it excellent strength and wear characteristics.

Clinician comments

Alessandro Castagna, MD at Humanitas Institute IRCCS, Milan, Italy, implanted the PyroTITAN® device in a 70 year old male with glenohumeral degenerative osteoarthritis and a concentrically worn glenoid. “Because of his active lifestyle, a total shoulder replacement with a typical stemmed humeral component was not desirable; we also wanted to avoid a potential periprosthetic fracture if the patient should fall,” said Dr. Castagna. “We chose the PyroTITAN® PyroCarbon humeral resurfacing as an alternative treatment. It also offered excellent wear characteristics against cartilage and bone when compared to metal alternatives, which allowed the glenoid to remain untouched.”

Bjorn Salomonsson MD, PhD at Danderyds Sjukhus Hospital in Stockholm, Sweden implanted the PyroTITAN® device in a 56-year-old female mail carrier, who had experienced shoulder problems for six years. “Radiographs and MRI showed ostheoarthrosis of the shoulder,” said Dr. Salomonsson. “We chose hemi resurfacing arthroplasty, since it is a bone-preserving procedure suitable for a person with good bone quality and, despite the ostheoarthrosis, a well preserved anatomy with a good glenoid. The PyroTITAN® implant was a good alternative because of the probability of less wear with PyroCarbon material than from a metal resurfacing replacement. The implant had a good anatomical fit to the original anatomy and was well fixated in the bone of the humeral head at surgery. The instrumentation was straightforward, well designed for the surgeon, and easy to adapt to the existing anatomy of the patient.”

The PyroTITAN® system is not currently available for sale in the United States.

Source: Integra Lifesciences, Globe Newswire