Biodegradable Kyphoplasty Balloon System Design and First In Man Study

Dr. Abdulrazzaq Alobaid has developed a novel biodegradable balloon and a corresponding biodegradable balloon system for encapsulating cement inserted into a cavity in a vertebra during kyphoplasty. The procedure is designed to provide structural stability and reduce pain caused by damaged vertebrae. The standard technique, vertebroplasty, is a minimally invasive procedure where high pressure cement is injected in to the vertebrae. Complications can arise with cement leakage. Kyphoplasty, creating a void in the vertebrae, was developed to utilize a low pressure cement injection as a way to decrease the leakage problems. However, complication with cement leakage still occur. Dr. Alobaid`s technology involves a patented biodegradable cement encapsulation balloon that is inserted in similar fashion as the standard cavity creating balloon in kyphoplasty, but the balloon is not retrieved. It is maintained in-situ and filled with a medical cement. The balloon is sealed with a special valve that prevents extravasation of the bone cement, mitigating complications related to cement leakage. The balloon dissolves at a later stage after the cement material is solidified.
Preliminary animal studies have been successfully completed with Dr. Alobaid`s biodegradable encapsulation balloon and support the functionality of the concept. Use of the biodegradable encapsulation balloon may represent a significant advancement that will provide improved safety and reduced risk when performing vertebral augmentation therapy; particularly in an outpatient setting. The goal of this research project is to conduct a thorough First in Man study to demonstrate the medical practicality and commercial viability of Dr. Alobaid`s invention. The following proposal provides a detailed approach to accomplishing this goal using industry standard medical practices aligned with international ethics and regulations.