Dr. Jeffrey L. Hendricks, Director of Engineering at Biotectix, was present during the surgical procedures and noted that, "The BT DOT coating allowed our partner to use a much smaller electrode and lead assembly than they have previously implanted. The assembly was also easier and faster for the surgeon to implant, which should result in reduced trauma to the patient, more reproducible orientation, and better placement. Early results also suggested the coated electrodes may enable faster and more effective stimulation of the GI tract."
The trial is the culmination of several months of activity with the device partner, from initial development and demonstration of the BT DOT coating on prototype designs in vitro to completion of stability, sterilization, and durability testing. In the final phases, devices suitable for human uses were prepared and necessary IRB documentation was submitted and approved prior to initiation of the study. Treatment of additional patients is anticipated in the coming months.
Dr. James Arps, General Manager at Biotectix, remarked, "The first human implants of devices incorporating the BT DOT technology is a tremendous accomplishment for Biotectix in demonstrating the safety and efficacy of our proprietary coating materials. This is the first of a number of successful clinical studies that we hope to complete with our various partners in the coming year."
Biotectix is developing a new class of conductive polymer materials and coatings for implantable devices and sensors that improve the safety, longevity, reliability, biological integration, and function of implantable biomedical devices. A number of benefits are driven by this platform technology without changing device size, shape, or implant procedure, including improved electrical performance, biocompatibility, and tissue response.
The technology addresses key limitations faced by the medical device industry including foreign body reactions, component stability, and long-term electrical performance in vivo. The materials are custom-designed for the specialized mechanical, electrical, and biological environments of the body, and provide an extremely high level of functional interfacing for medical electrodes.
Biotectix was formed by Allied Minds (www.alliedminds.com), a private equity company, based on technology originally developed at the University of Michigan, Ann Arbor. The founders and inventors continue to develop and validate the technology through research, collaborations, and partnerships with leading companies and research institutions. For more information please visit www.biotectix.com.
Posted by Sean Fenske, Editor-in-Chief, MDT