Sam Brusco, Associate Editor01.26.21
The U.S. Food and Drug Administration has granted clearance to OrthoSpin’s second generation, robotic, digitally enabled external fixation system for orthopedic treatments, the Generation 2 OrthoSpin system.
External fixation devices are commonly used for bone lengthening, setting complex fractures, and correcting deformities. Challenges in patient compliance and a lack of real-time feedback for clinician follow-up are especially challenging. Effective treatment currently requires patients to manually adjust fixation devices every day, necessitating complicated training for patients. This may cause adjustment errors and non-compliance, potentially resulting in poor clinical outcomes.
The firm completed initial U.S. and Israeli clinical cases with the FDA-cleared OrthoSpin Generation 1 system, which makes pre-programmed adjustments automatically without patient involvement. Integrated software lets physicians chart progress and immediately tweak treatment programs when needed. According to OrthoSpin, the second-generation is more user-friendly, covers all strut range sizes, and is 20 percent lighter.
"We are very excited to launch the Generation 2 OrthoSpin system," Dr. Assaf Dekel, Active Chairman of OrthoSpin said in a press release. "We believe that robotic automation will revolutionize the hexapod bone deformity market and we are proud to play a part in this transformation."
Future applications, such as the ability to follow and modify treatment plans via smart phones and cloud-based AI algorithms treatment plans based on computerized historical data, could play an increasingly prominent role in medicine and healthcare.
The OrthoSpin G2 system is approved in Israel and-cleared for use in USA and can be used with the DePuy Synthes MAXFRAME Multi-Axial Correction System.
External fixation devices are commonly used for bone lengthening, setting complex fractures, and correcting deformities. Challenges in patient compliance and a lack of real-time feedback for clinician follow-up are especially challenging. Effective treatment currently requires patients to manually adjust fixation devices every day, necessitating complicated training for patients. This may cause adjustment errors and non-compliance, potentially resulting in poor clinical outcomes.
The firm completed initial U.S. and Israeli clinical cases with the FDA-cleared OrthoSpin Generation 1 system, which makes pre-programmed adjustments automatically without patient involvement. Integrated software lets physicians chart progress and immediately tweak treatment programs when needed. According to OrthoSpin, the second-generation is more user-friendly, covers all strut range sizes, and is 20 percent lighter.
"We are very excited to launch the Generation 2 OrthoSpin system," Dr. Assaf Dekel, Active Chairman of OrthoSpin said in a press release. "We believe that robotic automation will revolutionize the hexapod bone deformity market and we are proud to play a part in this transformation."
Future applications, such as the ability to follow and modify treatment plans via smart phones and cloud-based AI algorithms treatment plans based on computerized historical data, could play an increasingly prominent role in medicine and healthcare.
The OrthoSpin G2 system is approved in Israel and-cleared for use in USA and can be used with the DePuy Synthes MAXFRAME Multi-Axial Correction System.