Balloon Spacers for Treatment of Irreparable Rotator Cuffs of the Shoulder

POLICY NUMBER

A.7.01.180

DESCRIPTION

Subacromial balloon spacer implantation represents a minimally invasive treatment modality for massive irreparable rotator cuff tears. The biodegradable spacer is introduced arthroscopically into the subacromial region where it functions to depress the humeral head, successfully reestablishing normal shoulder mechanics by blocking upward displacement of the humeral head toward the acromion. This technique addresses pain and functional limitations by creating a temporary articulating interface between the humeral head and acromion by reducing subacromial impingement. The biodegradable spacer gradually deflates over several months, potentially allowing time for adaptation of surrounding tissues and pain reduction without the complexity of tendon transfers or reverse shoulder arthroplasty.

Massive, Irreparable Full-Thickness Rotator Cuff Tears

Rotator cuff tears represent a common shoulder injury affecting a significant portion of the population, with overall incidence rates ranging from 5% to 40%, and approximately 54% of individuals over the age of 60 experiencing partial or complete tears. Massive tears, commonly defined as full-thickness tears involving at least 2 tendons or measuring greater than 5 cm in the coronal plane, constitute about 20% of all rotator cuff tears and 80% of recurrent tears. However, multiple definitions exist for what constitutes a massive tear, and a recent Delphi consensus of expert orthopedic shoulder specialists suggested that the most agreed upon definition would be tears with retraction of tendons to the glenoid rim in either the coronal or axial plane and/or a tear with at least 67% of the greater tuberosity exposed in the sagittal plane. Rotator cuff tears are considered irreparable when they cannot be restored to their original insertion on the tuberosities using standard surgical release and mobilization techniques due to excessive size, tendon retraction, and muscle degeneration, including atrophy and fatty infiltration. Without intervention, the natural progression of untreated massive tears can lead to muscle atrophy, fatty infiltration, and further tendon retraction, rendering potentially reparable tears irreparable over time.

Treatment

Management of massive, irreparable full-thickness rotator cuff tears (MIRCTs) encompasses both nonoperative and surgical approaches. Nonoperative treatments primarily focus on alleviating pain and enhancing shoulder function. These include physical therapy, activity modification to reduce strain on the shoulder, and pharmacological interventions such as nonsteroidal anti-inflammatory drugs (NSAIDs) and corticosteroid injections to manage inflammation and discomfort. Surgical interventions are considered when nonoperative treatments fail to provide adequate relief or in patients with higher functional requirements. Options include partial rotator cuff repair, which may restore some function depending on the tear's extent and tissue quality. For patients with significant deficits, tendon transfer procedures, such as latissimus dorsi or lower trapezius transfers, can compensate for lost rotator cuff function. Additionally, reverse total shoulder arthroplasty is a treatment option, particularly in individuals with pseudoparalytic shoulder, irreparable rotator cuff tears, and glenohumeral osteoarthritis who are not candidates for tendon transfers. Arthroscopic debridement with subacromial balloon spacer implantation (SBSI) is being investigated as a potential alternative treatment for managing MIRCTs.

In July 2021, the InSpace™ Subacromial Tissue Spacer System (Stryker; previously Ortho-Space Ltd.) was granted De Novo classification by the FDA (DEN200039; Product Code: QPQ). The device is a biodegradable subacromial balloon spacer indicated for the treatment of MIRCTs in patients at least 65 years of age with mild to moderate glenohumeral osteoarthritis who may benefit from a shorter surgical time compared to partial rotator cuff repair. The InSpace system consists of a resorbable polymer implant pre-loaded on a deployer, which is inflated with sterile saline after being positioned within the subacromial space. The inflated balloon aims to reduce acromiohumeral contact pressure and restore shoulder biomechanics while it remains inflated for 3 to 4 months and the device is designed to biodegrade over approximately 1 year. The device purports to result in shorter operative times as well as earlier functional and pain relief when compared to partial repair.

POLICY

Subacromial balloon spacer implantation is considered investigational as a treatment for massive, irreparable, full-thickness rotator cuff tears.

POLICY EXCEPTIONS

Federal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

POLICY HISTORY

08/15/2025: New policy added. Approved by the Medical Policy Advisory Committee.

SOURCE(S)

Blue Cross Blue Shield Association policy # 7.01.180

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

Investigational Codes

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