Frequently Asked Questions
What are the balloon materials?
The InSpace™ Balloon spacer is made from common biodegradable polymer (PLA and epsilon-caprolactone) that have been used for many years in the medical device industry.
Where is the device available?
The InSpace™ system has the CE mark and is commercially available in Europe. Please contact us directly for more details.
How long is the rehabilitation program?
The patient is expected to begin rehabilitation following balloon implantation. However,it should be decided on a case-by-case basis after you evaluate your patient’s condition.
Are there any adverse events associated with balloon use?
More than 2000 procedures were performed to date demonstrating a good safety profile with manageable adverse events. The main adverse events include device dislocation, local reaction, suspected infection and increase in pain. In rare cases (less than 2%), there was a need to remove the device. Generally any adverse events are mild and manageable by conservative treatment such as antibiotics, steroids and pain reduction medications.
What is the InSpace™ Balloon mechanism of action?
The shoulder is a complicated joint that requires the interconnected functioning of tendons, ligaments and bones. The InSpace™ Balloon, which is implanted between the acromion and the humeral head, creates a space between the bone structures, allowing smooth and frictionless gliding.
Who is an appropriate candidate for InSpace™ implantation?
Patient selection is an important and critical factor in every surgery. Clinical experience has shown that patients with massive tears with no osteoarthritis (OA) and preserved passive range of motion at a good level are appropriate candidates for the InSpace™ system.
Are there any contraindications for the use of InSpace™ system?
The InSpace™ Balloon Implant should not be implanted:
- Into areas with active or latent Infection or signs of tissue necrosis.
- If the patient has an allergy to the balloon material (PLA and/or caprolactone).
- If, after careful consideration, the surgeon determines the benefits of implanting the InSpace™ spacer don’t outweigh the risks, such as in some patients with deltoid palsy.
What have clinical studies demonstrated?
To date, two clinical studies were performed:
- A Pilot study was conducted in Slovenia that enrolled a total of 24 patients. Eighteen have already completed 4 years of follow up with continued improvements in their shoulder function.
Total Constant Score improved from an average of 34 to 69 points.
- A Post-Marketing Study is currently being conducted in Israel with 50 subjects. 6-12 months of post-operative follow up were completed, with average improvement of shoulder scores from ~36 points in baseline to ~67 points at 1-year follow-up.
Additional post-marketing studies are currently ongoing in several sites throughout Europe.