Medicrea announces FDA clearance of Tulip Genesis

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Tulip Genesis is a pedicle screw system and the first system offering a service for inventory control

The Medicrea Group announced today that it has received FDA clearance for Tulip Genesis, which completes its UNiD ASI platform technology.

With the FDA clearance of the Tulip Genesis, Medicrea completes its UNiD ASI platform by providing a top loading screw solution designed to integrate with UNiD ASI. According to a press release, Tulip Genesis is a state-of-the-art comprehensive top loading screw system that competes with any screw system on the market offering solutions for both degenerative and complex deformity cases.

Medicrea’s implant database integrated within the UNiD Hub now includes: IB3D, a selection of 3D-printed patient-specific interbody cages; UNiD Rod, a patient-specific rod industrially pre-bent to precisely match the optimal individual surgical simulation; Pass LP, a modular screw system; and Tulip Genesis, a top-loading screw system.

Medicrea’s proprietary UNiD ASI technology is a comprehensive suite of solutions comprising services and products designed to help surgeons improve their patient’s outcomes. By leveraging artificial intelligence and the latest clinical research, the platform enables the surgeon to plan cases preoperatively. The artificial intelligence (AI) embedded within the platform allows a surgeon to visualise the compensatory mechanisms above and below the instrumented spine that will most likely occur based on their surgical plan.

This technology offers solutions designed both for complex deformity and degenerative applications. The combination of AI with this product offering makes Medicrea the only manufacturer able to streamline inventory required to operate as well as provide patient-specific devices, through intelligent preoperative surgical planning.

“The combination of big data and patient-specific care is the new frontier,” says Chris Ames, director of spinal tumour and spinal deformity surgery at UCSF Medical Center, San Francisco, USA. “Medicrea’s technologies are specifically developed to that effect. They help surgeons better manage the entire clinical workflow, providing them with targeted relevant data, to help them better analyse and plan, leading to improved clinical results. Through the power of data collection and machine learning, a unique capability is created, allowing for a continuous cycle of improvement.”

The Medicrea’s UNiD Lab team of biomedical engineers can more efficiently generate comprehensive surgical plans, using outcome-centred predictive modelling algorithms to optimise surgical strategy. These documented UNiD surgical plans also allow the operating room staff to clearly anticipate when each implant will be needed by the surgeon. This is a critical combination as it streamlines the OR workflow with precise preselected implants and alignment of staff to the patient specific surgical plan and as it makes the surgery safer for the patient by reducing the chances for errors.

Denys Sournac, president and CEO, concludes: “To date, we have performed more than 4,000 cases using the UNiD ASI technology, with a strong and continuous adoption rate in the US of +47% since the beginning of the year. With the adoption of the UNiD ASI technology accelerating, Medicrea created a unique opportunity for a pull-through effect by offering surgeons a complete solution of implants. Tulip Genesis completes Medicrea’s portfolio to achieve full pull-through and incremental revenue”.

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