CE and FDA clearance for HP PRO Solution used for immobilization in proton therapy

October 15, 2015
13 October 2015 – Orfit Industries proudly announces that it has received CE and FDA clearance for its HP PRO Solution, an innovative immobilization system for use in proton therapy. The HP PRO Solution, fully designed and developed in house, fulfills the very specific requirements associated with Proton Therapy and offers a unique combination with Orfit’s cutting edge Nanor® immobilization masks, which are based on nanotechnology.

Orfit’s HP PRO Solution patient immobilization system has been designed to meet the very specific requirements associated with proton therapy. It includes a homogeneous low-density immobilization device with a narrow carbon fiber patient board in the head and neck area, allowing for closer range positions of the head of the proton machine. The board is a lightweight carbon fiber structure with good dosimetric properties. Nanor® thermoplastic mask are used to immobilize the head and neck of the patient.

Orfit Nanor® masks softly mold around the face, fitting like a glove. Comparison shows that immobilization masks developed by its competitors tend to be tighter and therefore less comfortable. The Nanor® material is less sensitive to shrinkage, an important feature for patients undergoing this type of lengthy treatment. However, thanks to the use of nanotechnology the masks offer a similar stability and reproducibility as the standard Orfit Efficast masks.

Orfit provides thermoplastic masks to be molded over the patient and securely and easily fastened to the patient board. Besides being thin and stable, the new thermoplastic material is very light, and contributes positively to the patient’s comfort. Like all other radiotherapy devices made by Orfit, the thermoplastic material is fully biocompatible and environmentally sustainable. Besides its reduced shipping costs because of a substantial gain in weight, its production requires less energy and the product can be recycled.

An important reason why more than average attention is paid to patient comfort is that proton therapy is increasingly being used in pediatric treatment. Comfort is imperative, considering that proton therapy sessions can take up to one hour whereas conventional radiation therapy sessions usually last only 10 to 15 minutes. With its specially designed and compatible fixation systems, the Orfit HP PRO Solution offers maximal immobilization required for the treatment to be successful.

Asked for a comment, Steven Cuypers, CEO of Orfit, stated: “Patient comfort has always been and continues to be one of our main priorities. We firmly believe that the Orfit HP PRO Solution, in combination with our nanotechnology-based masks, will contribute to alleviate discomfort and anxiety of patients, especially of the youngest.”

One of the leading oncological centers in the US has already selected Orfit’s newest immobilization device and will be using it in proton therapy treatment for brain, head and neck tumors.

It is not the first time that sophisticated Orfit technology is applied in high performance medical treatment. Elekta, a Swedish company and market leader in brain radiosurgery, selected Nanor®-reinforced masks and fixation systems developed by Orfit for treatment with its newest Gamma Knife, a high-precision irradiation machine for radiosurgery, ensuring extremely low levels of stress for the patient.