DRAFT

Latest Review Date:  April 2025

Category:  Musculoskeletal                                                 

POLICY:

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

DESCRIPTION OF PROCEDURE OR SERVICE:

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 > 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 ≥ 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 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.

KEY POINTS:

This policy was created in February 2025 with a search of the PubMed database. The most recent literature update was performed through February 3, 2025.

Summary of Evidence

For individuals with massive irreparable rotator cuff tears (MIRCTs) who receive subacromial balloon spacer implantation (SBSI) as an adjunct to routine care, including surgery, the evidence includes meta-analyses, RCTs, non-randomized comparative studies, and uncontrolled studies. Relevant outcomes are symptoms, morbid events, functional outcomes, and quality of life. Two RCTs provided conflicting evidence regarding the efficacy of SBSI. The non-inferiority trial comparing SBSI to partial repair found comparable improvements in American Shoulder and Elbow Surgeons (ASES) scores at 24 months, with SBSI demonstrating better forward elevation and shorter operative times. However, an FDA analysis recommended using a composite primary efficacy endpoint instead of ASES alone and found non-inferiority only in the subset of patients aged 65 years or older. Another RCT that compared arthroscopic debridement with and without SBSI was terminated early due to futility, with results favoring debridement alone over SBSI. This was supported by a 2024 meta-analysis comparing SBSI to arthroscopic debridement, which found that debridement alone demonstrated superior outcomes in pain reduction and Constant-Murley scores. A second review showed significant improvements in pooled patient-reported outcomes following SBSI from baseline through 2 years follow-up on Constant-Murley, ASES scores, and pain reduction, but a meta-analysis of comparative trials revealed no benefits over alternative therapies. Nonrandomized comparative studies typically reported improvements in functional outcomes and pain scores following SBSI compared to baseline; however, none showed it to be superior to other surgical reconstruction techniques. Case series have reported long-term follow-up of up to 8 years, with most showing a sustained benefit in functional and pain outcomes. Device-related complications were uncommon, with one review reporting that most studies (52%) did not observe any complications related to SBSI. Complications reported included implant migration, implant removal due to pain, early deflation of the implant resulting in temporary functional impairment, worsening of glenohumeral osteoarthritis, revision to other surgical procedures, and infection. Multiple studies emphasized the importance of proper patient selection and noted that while SBSI may provide short-term benefits, its long-term effectiveness compared to alternative treatments remains uncertain. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Practice Guidelines and Position Statements

American Academy of Orthopaedic Surgeons

The most recent American Society of Orthopedic Surgeons (AAOS) guidelines for the management of rotator cuff injuries do not provide guidance regarding the use of subacromial balloon spacer implantation for the treatment of rotator cuff tears or shoulder conditions.

National Institute for Health and Care Excellence

In 2023, the National Institute for Health and Care Excellence (NICE) published an interventional procedures guidance on the use of biodegradable subacromial spacer insertion for rotator cuff tears. For individuals where debridement is suitable, NICE recommends that subacromial spacers should not be used. When debridement is not a suitable option, NICE recommends that the procedure be only used in a research setting with patient selection done by a multidisciplinary team, including clinicians with specific training in the procedure due to limited evidence.

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Balloon, subacromial balloon spacer implantation, SSBI, InSpace, rotator cuff, shoulder, massive irreparable rotator cuff tears (MIRCTs)

APPROVED BY GOVERNING BODIES:

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 ≥ 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.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits. Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP contracts: Special benefit consideration may apply. Refer to member’s benefit plan.

CODING: 

CPT:

HCPCS:

REFERENCES:

1. American Academy of Orthopaedic Surgeons (AAOS). Evidence-based clinical practice guideline on the management of rotator cuff injuries. 2019. www.aaos.org/globalassets/quality-and-practice-resources/rotator-cuff/rotator-cuff-cpg-final-12-20-19.pdf.
2. Atoun E, Oulianski M, Bachar-Avnieli I, et al. Subacromial Balloon Spacer for Irreparable Rotator Cuff Tear Treatment Shows Improved Pain and Strength at 5-Year Follow-Up. Arthroscopy. Feb 2024; 40(2): 543-550.
3. Dabija DI, Jain NB. Minimal Clinically Important Difference of Shoulder Outcome Measures and Diagnoses: A Systematic Review. Am J Phys Med Rehabil. Aug 2019; 98(8): 671-676.
4. Davey MS, Kaar K. Clinical outcomes at medium-term follow-up of sub-acromial balloon spacer insertion in the operative management of massive rotator cuff tears. Ir J Med Sci. Aug 2022; 191(4): 1687-1691.
5. Deranlot J, Herisson O, Nourissat G, et al. Arthroscopic Subacromial Spacer Implantation in Patients With Massive Irreparable Rotator Cuff Tears: Clinical and Radiographic Results of 39 Retrospectives Cases. Arthroscopy. Sep 2017;33(9): 1639-1644.
6. Dhir R, Prinja A, Singh J, et al. The role of biodegradable spacer implantation under local anesthesia for patients with massive rotator cuff tears and significant medical comorbidities. JSES Rev Rep Tech. Aug 2022; 2(3): 310-314.
7. Familiari F, Nayar SK, Russo R, et al. Subacromial Balloon Spacer for Massive, Irreparable Rotator Cuff Tears is Associated With Improved Shoulder Function and High Patient Satisfaction. Arthroscopy. Feb 2021; 37(2): 480-486.
8. Fares MY, Koa J, Singh J, et al. The Insertion of a Subacromial Balloon Spacer Can Provide Symptom Relief and Functional Improvement at a Minimum 5-Year Follow-Up in Patients With Massive Irreparable Rotator Cuff Tears. Arthrosc Sports Med Rehabil. Apr 2024; 6(2): 100907.
9. Food and Drug Administration (FDA). De Novo Classification Request For Inspace Subacromial Tissue Spacer System.2020; www.accessdata.fda.gov/cdrh_docs/reviews/DEN200039.pdf.
10. Galardini L, Coppari A, Pellicciari L, et al. Minimal Clinically Important Difference of the Disabilities of the Arm, Shoulder and Hand (DASH) and the Shortened Version of the DASH (QuickDASH) in People With Musculoskeletal Disorders: A Systematic Review and Meta-Analysis. Phys Ther. May 01 2024; 104(5).
11. García Moreno J, Correa Bellido P, Salazar Aguilar JR, et al. Results after the application of biodegradable spacer balloons as a therapeutic option in non-repairable massive ruptures of the shoulder rotator cuff. Rev Esp Cir Ortop Traumatol. 2022; 66(1): 68-73.
12. Garofalo R, De Crescenzo A, Fontanarosa A, et al. Rotator cuff repair protected with subacromial balloon spacer shows a low rate of non-healing. Knee Surg Sports Traumatol Arthrosc. Jun 2022; 30(6): 2123-2129.
13. Garríguez-Pérez D, Lópiz Y, García-Fernández C, et al. Poor Results After Arthroscopic Treatment of Irreparable Rotator Cuff Tears Using a Subacromial Balloon Spacer. J Am Acad Orthop Surg. Oct 01 2022; 30(19): e1260-e1268.
14. Gervasi E, Maman E, Dekel A, et al. Fluoroscopically Guided Subacromial Spacer Implantation for Massive Rotator Cuff Tears: Two Years of Prospective Follow-up. Orthop J Sports Med. Apr 2021; 9(4): 2325967121993469.
15. Gervasi E, Maman E, Dekel A, et al. Fluoroscopy-guided biodegradable spacer implantation using local anesthesia: safety and efficacy study in patients with massive rotator cuff tears. Musculoskelet Surg. Dec 2016; 100(Suppl 1): 19-24.
16. Holschen M, Brand F, Agneskirchner JD. Subacromial spacer implantation for massive rotator cuff tears: Clinical outcome of arthroscopically treated patients. Obere Extrem. 2017; 12(1): 38-45.
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18. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
19. Juhan T, Stone M, Jalali O, et al. Irreparable rotator cuff tears: Current treatment options. Orthop Rev (Pavia). Sep 242019; 11(3): 8146.
20. Kaisidis A, Pantos P, Bochlos D. The subacromial spacer system for irreparable posterosuperior rotator cuff tears: A retrospective study of 47 patients with a two-year follow-up. Shoulder Elbow. Jul 2022; 14(1 Suppl): 76-82.
21. Kishan A, Russo R, Goldfarb SI, et al. Arthroscopic Subacromial Balloon Spacer for Massive Rotator Cuff Tears Demonstrates Improved Shoulder Functionality and High Revision-Free Survival Rates at a Minimum 5-Year Follow-Up. Arthroscopy. Jun 22 2024.
22. Kovacevic D, Suriani RJ, Grawe BM, et al. Management of irreparable massive rotator cuff tears: a systematic review and meta-analysis of patient-reported outcomes, reoperation rates, and treatment response. J Shoulder Elbow Surg. Dec 2020; 29(12): 2459-2475.
23. Kukkonen J, Kauko T, Vahlberg T, et al. Investigating minimal clinically important difference for Constant score in patients undergoing rotator cuff surgery. J Shoulder Elbow Surg. Dec 2013; 22(12): 1650-5.
24. Malahias MA, Brilakis E, Avramidis G, et al. Arthroscopic partial repair with versus without biodegradable subacromial spacer for patients with massive rotator cuff tears: a case-control study. Musculoskelet Surg. Dec 2021; 105(3): 247-255.
25. Malahias MA, Brilakis E, Avramidis G, et al. Satisfactory mid-term outcome of subacromial balloon spacer for the treatment of irreparable rotator cuff tears. Knee Surg Sports Traumatol Arthrosc. Dec 2019; 27(12): 3890-3896.
26. Maman E, Kazum E, Abboud JA, et al. Biodegradable balloon spacer for massive irreparable rotator cuff tears is associated with improved functional outcomes, low revisions, and complications rate at minimum one year follow-up. IntOrthop. Mar 2022; 46(3): 573-579.
27. McClure NS, Sayah FA, Xie F, et al. Instrument-Defined Estimates of the Minimally Important Difference for EQ-5D-5LIndex Scores. Value Health. Apr 2017; 20(4): 644-650.
28. McLaughlin RJ, Whitson AJ, Panebianco A, et al. The minimal clinically important differences of the Simple Shoulder Test are different for different arthroplasty types. J Shoulder Elbow Surg. Aug 2022; 31(8): 1640-1646.
29. Metcalfe A, Arnold S, Parsons H, Parsons N, Bhabra G, Brown J, Bush H, Diokno M, Elliott M, Fox J, Gates S, Gemperl Mannion E, Haque A, Hutchinson C, Kearney R, Khan I, Lawrence T, Mason J, Rahman U, Stallard N, Ul-Rahman S, Viswanath A, Wayte S, Drew S, Underwood M. Subacromial spacers for adults with symptomatic, irreparable rotator cuff tears: the START:REACTS novel group sequential adaptive RCT. Southampton (UK): National Institute for Health and Care Research; 2023 Aug.
30. Minarro JC, Bassi C, Boltuch A, et al. Subacromial Balloon Spacer Does Not Reduce the Retear Rate for Massive Rotator Cuff Tears: A Comparative Study. Arthroscopy. Feb 2024; 40(2): 242-248.
31. National Institute For Health And Care Excellence (NICE). Biodegradable subacromial spacer insertion for rotator cuff tears (Interventional procedures guidance [IPG775]). Nov 2023. www.nice.org.uk/guidance/ipg775.
32. Novi M, Kumar A, Paladini P, et al. Irreparable rotator cuff tears: challenges and solutions. Orthop Res Rev. 2018; 10: 93-103.
33. Oh JH, Park JH, Jeong HJ, et al. Comparing Clinical Outcomes After Subacromial Spacer Insertion Versus Other Reconstruction Methods in the Treatment of Irreparable Massive Rotator Cuff Tears. Orthop J Sports Med. Sep 2019;7(9): 2325967119869600.
34. Piekaar RSM, Bouman ICE, van Kampen PM, et al. Early promising outcome following arthroscopic implantation of the subacromial balloon spacer for treating massive rotator cuff tear. Musculoskelet Surg. Dec 2018; 102(3): 247-255.
35. Piekaar RSM, Bouman ICE, van Kampen PM, et al. The subacromial balloon spacer for massive irreparable rotator cuff tears: approximately 3 years of prospective follow-up. Musculoskelet Surg. Aug 2020; 104(2): 207-214.
36. Prat D, Tenenbaum S, Pritsch M, et al. Sub-acromial balloon spacer for irreparable rotator cuff tears: Is it an appropriate salvage procedure?. J Orthop Surg (Hong Kong). 2018; 26(2): 2309499018770887.
37. Ricci M, Vecchini E, Bonfante E, et al. A clinical and radiological study of biodegradable subacromial spacer in the treatment of massive irreparable rotator cuff tears. Acta Biomed. Oct 18 2017; 88(4S): 75-80.
38. Ruiz Ibán MA, Lorente Moreno R, Ruiz Díaz R, et al. The absorbable subacromial spacer for irreparable posterosuperior cuff tears has inconsistent results. Knee Surg Sports Traumatol Arthrosc. Dec 2018; 26(12): 3848-3854.
39. Sandler AB, Gil LG, Scanaliato JP, et al. Subacromial Balloon Placement Demonstrates No Advantage Over Debridement in the Treatment of Massive Irreparable Rotator Cuff Tears: A Dual-Armed Systematic Review and Meta-analysis of Over1000 Patients. Am J Sports Med. Mar 2024; 52(4): 1088-1097.
40. Savarese E, Aicale R, Romeo R, et al. Shoulder balloon spacer for massive irreparable rotator cuff tears results insignificant improvements. Knee Surg Sports Traumatol Arthrosc. Aug 27 2024.
41. Schumaier A, Kovacevic D, Schmidt C, et al. Defining massive rotator cuff tears: a Delphi consensus study. J Shoulder Elbow Surg. Apr 2020; 29(4): 674-680.
42. Senekovic V, Poberaj B, Kovacic L, et al. Prospective clinical study of a novel biodegradable sub-acromial spacer in treatment of massive irreparable rotator cuff tears. Eur J Orthop Surg Traumatol. Apr 2013; 23(3): 311-6.
43. Senekovic V, Poberaj B, Kovacic L, et al. The biodegradable spacer as a novel treatment modality for massive rotator cuff tears: a prospective study with 5-year follow-up. Arch Orthop Trauma Surg. Jan 2017; 137(1): 95-103.
44. Sewpaul Y, Sheean AJ, Rashid MS, et al. Subacromial Balloon Spacer for the Massive Irreparable Cuff Tear. Curr Rev Musculoskelet Med. Feb 2024; 17(2): 47-57.
45. Sirignano M, Nyland J, Krupp R. "Surviving the dip" after subacromial balloon spacer implantation for massive rotator cuff tear treatment: a retrospective case series. Eur J Orthop Surg Traumatol. Nov 14 2024; 35(1): 1.
46. Sirignano M, Nyland J, Krupp R. Subacromial balloon spacer massive rotator cuff tear treatment systematic review and meta-analysis: Patient selection and physical therapy may be keys to outcome success. Knee Surg Sports Traumatol Arthrosc. Sep 2025; 32(9): 2346-2357.
47. Stryker. InSpace Balloon Implant. 2024; www.stryker.com/content/dam/stryker/sports-medicine/products/inspace/images/InSpace_Brochure_1000903813RevB.pdf.
48. Tashjian RZ, Deloach J, Porucznik CA, et al. Minimal clinically important differences (MCID) and patient acceptable symptomatic state (PASS) for visual analog scales (VAS) measuring pain in patients treated for rotator cuff disease. J shoulder Elbow Surg. 2009; 18(6): 927-32.
49. Tashjian RZ, Hung M, Keener JD, et al. Determining the minimal clinically important difference for the American Shoulder and Elbow Surgeons score, Simple Shoulder Test, and visual analog scale (VAS) measuring pain after shoulder arthroplasty. J Shoulder Elbow Surg. Jan 2017; 26(1): 144-148.
50. van Kampen DA, Willems WJ, van Beers LW, et al. Determination and comparison of the smallest detectable change (SDC) and the minimal important change (MIC) of four-shoulder patient-reported outcome measures (PROMs). J Orthop Surg Res. Nov 14 2013; 8: 40.
51. Vecchini E, Gulmini M, Peluso A, et al. The treatment of irreparable massive rotator cuff tears with inspace balloon: rational and medium-term results. Acta Biomed. Mar 10 2022; 92(S3): e2021584.
52. Verma N, Srikumaran U, Roden CM, et al. InSpace Implant Compared with Partial Repair for the Treatment of Full-Thickness Massive Rotator Cuff Tears: A Multicenter, Single-Blinded, Randomized Controlled Trial. J Bone Joint Surg Am. Jul 20 2022; 104(14): 1250-1262.
53. Yallapragada RK, Apostolopoulos A, Katsougrakis I, et al. The use of a subacromial spacer-inspace balloon in managing patients with irreparable rotator cuff tears. J Orthop. Sep 2018; 15(3): 862-868.
54. Yamak K, Karahan HG, Altay T, et al. Is Subacromial Balloon Spacer Appropriate for Treatment of Irreparable Rotator Cuff Tears in Elderly Patients?. Ortop Traumatol Rehabil. Dec 31 2019; 21(6): 417-426.

POLICY HISTORY:

Medical Policy Panel, April 2025

Medical Policy Group, April 2025 (7): New medical policy. Available for comment May 1, 2025 through June 15, 2025. Balloon spacers for treatment of irreparable rotator cuffs of the shoulder previously non-covered per MP 495- Investigational Criteria.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;
2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;
3. The technology must improve the net health outcome;
4. The technology must be as beneficial as any established alternatives;
5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and
2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and
3. Not primarily for the convenience of the patient, physician or other health care provider; and
4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.