Biodegradable subacromial balloon implant
The InSpace™ implant is a first-of-its-kind biodegradable subacromial balloon spacer designed for the arthroscopic treatment of massive irreparable rotator cuff tears (MIRCTs).
Originally developed by Israel-based orthopaedic devices firm OrthoSpace, the InSpace implant was added to Stryker’s portfolio after Stryker acquired OrthoSpace in March 2019.
The InSpace balloon provides a shorter, less invasive option for surgeons in shoulder care, facilitating continuous, clinically substantial improvements in the function and symptoms of the patient’s shoulder.
The device received clearance from the US Food and Drug Administration (FDA) in July 2021. InSpace holds CE Mark certification and is marketed in Europe, Russia, Israel and several Latin American and Asian countries.
The device already has a decade-long successful clinical experience, with 29,000 balloons implanted outside the US. Level I research was completed across North America before the device entered the US market.
MIRTCs are considered irreparable according to the preprocedural magnetic resonance imaging (MRI) or intra-operative assessment, which makes it physically and biologically challenging for the surgeon to repair them.
Current techniques for MIRCT treatments may require lengthy and frustrating patient rehabilitation processes.
The average rate of rotator cuff re-tear following surgery is around 20% to 40%, while the failure rates of massive tears can reach 70%. An option to significantly reduce the patient’s pain has been highly sought-after by surgeons.
The InSpace biodegradable implantable balloon system includes an introducer and a pre-shaped balloon spacer made of a biodegradable copolymer that biodegrades over the course of 12 months. It is a single-use medical device.
The implant is designed to restore the subacromial space without the need for sutures, fixation devices or any kind of discomfort. It is claimed to be able to improve shoulder mobility and function.
The balloon is inserted using a cylinder-shaped insertion tube, which is withdrawn once the spacer is placed into the subacromial space. It is implanted, either arthroscopically or via a five-step mini-open surgery, between the acromion and the humeral head or rotator cuff. It creates a space between the bone structures, allowing the humeral head to glide smoothly or frictionless against the acromion.
The InSpace system is delivered sterile and is free of latex and phthalates.
The InSpace balloon implant is indicated for the treatment of full-thickness MIRCTs due to trauma or degradation with mild to moderate glenohumeral osteoarthritis in patients aged 65 years or older and whose clinical conditions may improve by a shorter surgical time treatment compared with the partial rotator cuff repair.
The implant is said to be a game-changing treatment for the arthroscopic repair of large irreparable rotator cuff injuries. The efficient treatment also delivers long-term patient benefits.
The FDA’s approval of the InSpace balloon implant was based on the outcome of a prospective, single-blinded, multi-centre, randomised, controlled, pivotal clinical trial. This was conducted to assess the safety and efficacy of the InSpace device implantation compared with the surgical partial repair of full-thickness MIRCT.
A total of 184 patients were randomised to receive either arthroscopic InSpace (sub-acromial tissue spacer system) implantation or arthroscopic partial repair of the rotator cuff.
In the primary safety outcome, InSpace was found to be non-inferior to the partial repair and demonstrated a high rate of clinical success (87.8%), compared with partial repair (88.1%), at 24 months.
InSpace offered a substantial advantage in that the operating time only took 44 minutes, whereas the partial repair took 71 minutes.
Results showed similar rates of subsequent secondary surgical intervention during the study and clinically substantial improvements in shoulder function and symptoms after two years. No serious adverse device effects (SADEs) were observed in patients at any point in the study.
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