According to Israeli business newspaper Globes, a local company called OrthoSpace Ltd. has obtained CE Mark of approval for its product, the InSpace balloon, which is designed to be a temporary bursa-like padding for patients suffering from rotator cuff tears.
A spokesperson for the company tells us the following about the device:
Massive Rotator cuff tears present both a physical and biological challenge to the surgeon attempting to repair them. The tear is considered irreparable according to pre-procedural MRI imaging or intra-operative assessment. The cuff tissue is often retracted and degenerated. The muscle tissue can be atrophied and with fat infiltratation.
While the average rate of rotator cuff re-tear post repair is approximately 20-40%, failure rates of massive tears can approach 100%. Surgeons are looking for a solution which will reduce significantly their patient pain.
By having the Biodegradable InSpace™ Balloon implanted between the acromion and the humeral head, a space is created between the bone structures; allowing for smooth and frictionless gliding. The InSpace™
Balloon demonstrated successfully pain reduction and ROM improvement, with very high safety profile.
The Balloon was initially designed for chronic, massive, non-reparable rotator-cuff tears; enabling leverage of other muscles. The Balloon may be inserted arthroscopically, or with a mini-open procedure.
The InSpace™ Balloon surgical technique is only five steps of fast and elegant procedure, which has the potential for a quick rehabilitation program.
Globes: Orthospace obtains CE Mark for shoulder balloon implant…
Company page: OrthoSpace …