Shoulder Resurfacing - HemiCAP Product Overview

The Arthrosurface HemiCAP shoulder resurfacing system is a surgical method for the treatment of localized cartilage lesions and defects in the major joints. This system is comprised of three elements; a three-dimensional mapping technology, a set of instruments to map and prepare the damaged area and a cobalt-chrome and titanium implant. The system precisely aligns the surface of the implant to the contours of the patient's articular cartilage surface, thus filling the defect and restoring a smooth and continuous articular surface. The HemiCAP system has been developed so that it can be utilized via minimally disruptive surgical techniques.

There are two high prevalence shoulder injuries that can be correlated to a significant number of cartilage pathologies: dislocations and rotator cuff injuries. There are estimates that rotator cuff injuries occur in approximately 400,000 cases worldwide each year. It is estimated that in at least 10% of these cases, there is also a large humeral head injury with fully exposed bone. Therefore, Arthrosurface estimates that there are approximately 40,000 cases per year where the HemiCAP implant could be used to address a full-cartilage defect in the  shoulder associated with a rotator cuff injury.

Shoulder dislocations result from either a forceful collision, falling on an outreached arm or a sudden wrenching movement. A complication of primary dislocation is subsequent recurrent dislocations. It is estimated that there are approximately 500,000 shoulder dislocations in the U.S. annually and approximately 500,000 outside the U.S.  In approximately 60% of shoulder dislocations, patients will develop humeral head injuries whereby the bone and cartilage on the surface of the humeral head will be  affected. Using these figures, it is believed that as many as 100,000 cases per year related to a shoulder dislocation could be candidates for the HemiCAP shoulder system.

Shoulder replacements are not performed as frequently as those for knees and hips due to several factors: cartilage defects and injuries appear to be better tolerated with less pain and loss of motion in the shoulder, replacement surgery can be more difficult than other joints and outcomes have been inconsistent causing many physicians to use more conservative treatments. Arthrosurface estimates that approximately 80,000 shoulder arthroplasties are performed worldwide each year, mostly for degenerative joint disease (DJD), with  approximately 42,000 performed in the U.S. 

The HemiCAP Instrument Set enables the surgeon to accurately place the implant and precisely map the curves of the articular surface, in real-time, under direct or arthroscopic visualization, with no angle-induced errors or magnification errors that might exist with MRI, or X-ray imaging techniques.

The HemiCAP system is intended to provide an effective interim means for managing pain and disability in the middle-aged patient until a total joint replacement treatment option becomes more necessary, and is part of a clinical treatment strategy to help avoid early-age-revision scenarios. The prosthetic may also provide a treatment option for the older patient who may not tolerate the morbidity of a total joint replacement procedure.

The HemiCAP implants and instruments are designed to remove a minimal amount of bone stock, preserve functional structures and tissues, and allow for an uncomplicated removal in the event of revision.