Patient-Powered Smart Implants Improve Spinal Fusion Outcomes

Smart implants are poised to transform the way spine and orthopedic surgeons treat patients. The concept of powering implantable sensors and promoting bone healing through human motion alone, without batteries or external stimulators, is nothing short of revolutionary. Now, a new generation of human-powered smart implants could enhance the body's natural healing abilities and provide unprecedented post-operative implant data for both physicians and patients.

DirectSync Surgical (Lawrence, KS, USA) is developing the first-ever patient-powered smart implant, which minimizes the need for continuous powering and remote monitoring of the device. As the patient goes about their daily activities, the DirectSync interbody actively provides targeted mechanically synced electrical stimulation for enhanced bone healing and post-operative data collection. This information helps to refine and optimize the treatment plan between the physician and patient.

DirectSync harnesses the human body's mechanical biofeedback system to create fully integrated smart implants that sense load and electrically stimulate bone growth at the primary implantation site, eliminating the need for batteries or external stimulators. The company's proprietary technology replicates the natural healing properties of bone by producing a small pulse of DC electrical stimulation in sync with each step the patient takes. This core innovation has applications across multiple load-bearing orthopedic implants.

DirectSync's patient-powered smart spinal fusion device delivers localized electrical stimulation and offers post-operative diagnostics to achieve fusion more effectively for patients requiring spinal fusion. The product could provide a more effective treatment for irreversibly debilitating conditions compared to the current standard of care. The US Food and Drug Administration has granted Breakthrough Device Designation to DirectSync's patient-powered smart spinal fusion device. To meet the designation criteria, the FDA reviewed the company's preliminary data and determined that the DirectSync Surgical interbody device may offer a more effective treatment for irreversibly debilitating conditions than the current standard of care.

"Today's announcement is an important milestone for DirectSync Surgical and highlights the urgent need to improve spinal fusion outcomes while empowering physicians and their patients with a more robust post-operative continuum of care," said Zygmunt Porada, CEO of DirectSync Surgical. “Obtaining breakthrough designation from FDA indicates our technology will significantly improve the standard of care and provide more timely access to patients and health care providers.”

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