CMS grants outpatient facility code for insertion of Stryker's InSpace subacromial balloon spacer

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Apr 11, 2022, 06:59 ET

The new code enables greater access to patients and surgeons in the treatment of massive irreparable rotator cuff tears

KALAMAZOO, Mich., April 11, 2022 /PRNewswire/ -- Stryker announced today The United States Centers for Medicare & Medicaid Services (CMS) has established a new Healthcare Common Procedure Coding System (HCPCS) code C9781 for outpatient hospitals and ambulatory surgery centers to report the insertion of Stryker's InSpace balloon implant, effective April 1.

The new HCPCS code will be used to facilitate the process of health insurance claims for individuals enrolled in Medicare and other health insurance programs, allowing for more patients to have access to care with InSpace.

Massive irreparable rotator cuff tears (MIRCTs) are one of the most common causes of shoulder dysfunction, and about 10 million Medicare beneficiaries are estimated to have such tears with prevalence increasing with age.^1,2,3

The InSpace balloon implant* is a breakthrough solution in the shoulder continuum of care that addresses massive irreparable rotator cuff tears and provides a new, simple surgical treatment option, allowing surgeons to better meet the needs of their patients. InSpace is designed to restore the subacromial space, provides a less invasive solution compared to other surgical treatment options that require fixation devices or grafts and has been demonstrated to improve shoulder motion and function.⁴

"Pursuing an HCPCS code for InSpace has been a top priority for us to enable greater access for patients and surgeons in the treatment of MIRCTs," said Matt Moreau, Stryker's Sports Medicine Vice President and General Manager. "Reimbursement for new technologies can be a significant barrier for healthcare professionals and their patients. We are excited about the CMS code decision and are committed to continuing to provide opportunities to help create better care and access for patients."

About the decision

The CMS decision was based on findings from the Level 1 InSpace pivotal study – a prospective, single-blinded, multi-center, randomized, controlled trial which assessed the safety and effectiveness of the InSpace Implant (IS) compared to Partial Repair (PR). The study evaluated 184 (n=93 IS; n=91 PR) randomized patients > 40 years of age with symptomatic massive full thickness rotator cuff tears that failed non-operative management, through 24 months of follow-up.⁴

More information about the InSpace balloon implant is available at www.stryker.com/inspace.

About Stryker

Stryker is one of the world's leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Medical and Surgical, Neurotechnology, Orthopaedics and Spine that help improve patient and hospital outcomes. More information is available at www.stryker.com.

Media contact
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Phone: 408 529 7512

^1.Novi M, et al. Irreparable rotator cuff tears: challenges and solutions. Orthop Res Rev. 2018; 10:93-103.

^2.Yamamoto A, et al. Prevalence and risk factors of a rotator cuff tear in the general population. J Shoulder Elbow Surg. 2010; 19(1):116-120.

^3.Minagawa H, et al. Prevalence of symptomatic and asymptomatic rotator cuff tears in the general population: From mass-screening in one village. J Orthop. 2013; 10(1):8-12.

^4.A prospective, single-blinded, multi-center, randomized, controlled, pivotal study to assess the safety and effectiveness of the InSpace device, compared to arthroscopic partial repair, for treatment of full thickness massive rotator cuff tears (MRCT). NCT02493660

*The InSpace™ subacromial tissue spacer system is indicated for the treatment of patients with massive, irreparable full-thickness torn rotator cuff tendons due to trauma or degradation with mild to moderate gleno-humeral osteoarthritis in patients greater than or equal to 65 years of age whose clinical conditions would benefit from treatment with a shorter surgical time compared to partial rotator cuff repair.

SOURCE Stryker