FDA Clears French TULIP

The Medicrea Group has received FDA 510(k) Clearances for the company’s PASS Tulip top-loading fixation construct and its UNiD HUB digital portal for the company’s Adaptive Spine Intelligence (ASI).

PASS TULIP Construct

The construct, according to the June 16, 2017 company announcement, is the world’s first patient-specific hybrid construct.

The components are fully compatible with Medicrea’s PASS LP to provide a hybrid approach in complex indications. The first-ever patient-specific hybrid spine surgery was successfully performed by Frank Schwab, M.D., Chief of Spine, at the Hospital for Special Surgery in New York.

Schwab said by using two compatible implant designs in a hybrid application, the surgeon can personalize a patient’s operation in a whole new way. “The increased flexibility and precision help me to best achieve the patient’s optimal spinal alignment targeted by Medicrea’s patient-specific implants.” Schwab uses the company’s UNiD ASI technology to plan cases supported by the UNiD LAB team. “Having these additional tools to achieve my surgical strategy translates to better alignment post-operatively and that’s clearly been shown to correlate with patient satisfaction and with long-term benefits of surgery,” added Schwab.

Company President and CEO Denys Sournac notes the company’s LifeTime Warranty covering Medicrea’s rod constructs now include associated PASS TULIP components. “The addition of PASS TULIP to our comprehensive implant range will open new doors for Medicrea to gain market share for our UNiD ASI technology by lowering the barrier to entry for the large number of surgeons trained on top-loading instrumentation.”

The company says the PASS Tulip components are differentiated from traditional top-loading implants by a “thoughtful proprietary design” that allows a single implant to perform multiple clinical functions through a simple one-step maneuver. “The anticipated result is increased surgical efficiency in implant placement as well as a reduction in the inventory required for a case and associated processing costs.”

UNiD HUB Software

The newly FDA cleared UNiD HUB, according to the company, is designed to support the surgeon workflow, identify tendencies and correlations and build predictive modeling to drive intelligent strategic decisions and create personalized implant solutions for surgery. “The software also serves to enhance the existing proprietary IT utilized by Medicrea’s UNiD ASI platform for digital surgical planning to create a seamless communication channel between the Company’s UNiD LAB biomedical engineers and surgeon users to deliver UNiD TEK, patient-specific spinal implants manufactured by Medicrea through proprietary rod bending and 3D printing techniques.”

The digital communication portal opened with the introduction of UNiD HUB, says the company, “instantly creates a sticky, user-friendly environment for surgeons to track and manage their open cases in both snapshot and detailed views, access their complete history with post-operative analyses and dialogue with a dedicated biomedical engineer in real time. Future functionalities will become available alongside the software’s wide release planned in October of 2017.”

Sournac says the company has received very positive feedback from surgeon customers who have seen beta versions of the software and the company is now ready to make the digital portal immediately available to them. “The software integrates well with their clinical habits and enhances their experience with UNiD ASI technology. This new generation of software will be more than a communication tool for surgeons—it will grant surgeons access to the same data analytics and machine learning technology that is curated by our data scientists to use the UNiD HUB as an unparalleled research engine and networking platform.”

The software has been developed in desktop and mobile applications and is accessible from medical offices as well as on the go.