Clear Catheter Systems said the device can be widely deployed in the post operative management of patients requiring heart and lung surgery.
The company also had approval to market the device in Europe and Canada, and the regulatory approval clears the way to market the product in the US for patients recovering from cardiothoracic surgery.
The PleuraFlow System employs a proprietary active tube clearance system which allows the medical professional to maintain a functioning chest tube in the post operative period.
Clear Catheter Systems CEO Edward Boyle said the device has the potential to help minimise the risk of surgery, avoid complications and reduce the cost of care for patients recovering from heart surgery.
