The US Food and Drug Administration (FDA) has granted clearance to Stryker’s InSpace balloon implant for arthroscopic therapy of massive irreparable rotator cuff tears (MIRCTs) for sustained improvements in patients.
InSpace offers surgeons the latest option for shoulder continuum of care that aids them to better meet the patients’ requirements.
Acquired from OrthoSpace in 2019, InSpace is the first-of-its-kind balloon to be launched in the US market, Stryker noted.
Indicated for treating irreparable full-thickness torn rotator cuff tendons caused by trauma, the balloon implant can restore the subacromial space without sutures or fixation devices.
The device was shown to enhance shoulder motion and function.
InSpace can also be used in people aged 65 years or above having rotator cuff tendon degradation with mild to moderate gleno-humeral osteoarthritis.
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In this population, the device is intended for clinical conditions that can benefit from therapy with a shorter surgical time versus partial rotator cuff repair.
Stryker sports medicine vice-president and general manager Matt Moreau said: “We are extremely excited about the clearance of InSpace because it provides a new surgical option for surgeons to address their unmet MIRCT needs in the shoulder continuum of care.
“We are committed to the advancement of shoulder arthroscopy, and InSpace offers a unique opportunity for us to better partner with our customers on their clinical objectives to improve patient outcomes around a very challenging pathology in the shoulder.”
The implant has a clinical history of more than ten years with 29,000 balloons implanted outside the US and in the Level I study carried out in North America.
Stryker has also unveiled its Tornier shoulder arthroplasty portfolio and introduced Perform Humeral Stem, the first new Tornier product.
The Tornier Perform Humeral Stem provides clinical solutions for both simple and complex shoulder arthroplasty cases. It is meant for anatomic, reverse and hemiarthroplasty of the shoulder.
Also, the product facilitates the change from an anatomic to a reverse shoulder prosthesis during revision.
In August last year, Stryker launched Surpass Evolve Flow Diverter in the US, following its approval by the FDA.