Becker's Spine Review

34 DEVICES & IMPLANTS Stryker spine device granted transitional pass-through payment for 2021 By Alan Condon S pineJack, an implantable fracture reduction system, has qualified for CMS' transitional pass-through payment as part of the 2021 Medicare Hospital Outpatient Prospective Payment System. TPT status provides additional payments for new devices that show a substantial clinical improvement over existing technologies. Beginning Jan. 1, the TPT payment will provide outpatient facilities with incremental Medicare payment for SpineJack for up to three years. In September, CMS awarded SpineJack with the new technology add-on payment, which provides additional payment in the hospital inpatient setting. "Due to the SpineJack System receiving both NTAP and TPT pay- ment, physicians and administrators no longer have to make a deci- sion between care and cost," Greg Siller, vice president and general manager of Stryker's interventional spine business, said in a Dec. 4 news release. "The CMS TPT payment determination is a monumental step in pro- viding a superior device technology in the treatment of osteoporotic vertebral compression fractures." SpineJack is the 11th device to receive TPT status since 2016. n Spinal interbody granted breakthrough device designation By Alan Condon T he FDA has awarded Carlsmed's aprevo device its break- through device designation, which will expedite the time it takes to reach clinical trials. The device is the only spine technology to receive the FDA's break- through device designation and is now available for use. "Obtaining breakthrough designation means the FDA believes that aprevo could improve the standard of care and wants to provide patients with more timely access to this technology," CEO Mike Cor- donnier said in a Dec. 8 news release. Aprevo is a patient-specific interbody for the treatment of adult spi- nal deformity, and the first Carlsmed device to receive FDA clear- ance and breakthrough device designation. Aprevo also qualified for CMS' alternative inpatient new technology add-on payment track for "transformative new devices," beginning with NTAP applications for fiscal year 2021. CMS is reviewing the device for its NTAP application for fiscal year 2022. If approved, hospitals will receive additional CMS payment of up to 65 percent of the cost of aprevo. n Aspen Surgical acquires Iowa medical device company By Alan Condon A spen Surgical has acquired Protek Medical Products, a device company developing guidance tools for instruments used in imag- ing procedures, among other products. The acquisition includes Protek's Pull-Up probe cover technology, designed to improve clinical efficiency. The transaction will help Aspen Surgical "ad- dress cross-contamination issues in the clinical environment" and provide more "single-use medical devices that improve safety and effi- ciency," Aspen Surgical CEO Jason Krieser said in a Nov. 24 news release. Protek CEO Rick Pruter said the deal will help "expand our new product development oppor- tunities" and improve "patient safety in the im- aging market." n MedStar hospital surpasses 50 spine surgeries with Brainlab Cirq robot By Alan Condon M edStar Washington Hospital Center in Washington, D.C., has completed more than 50 spine surgeries with the Cirq robotic arm since it installed the device this summer, WTOP reports. Cirq is a cost effective solution which integrates with Brainlab navigation and imaging technol- ogies and is designed to increase surgical pre- cision, reduce radiation exposure and stream- line workflow in the OR. The robot received FDA clearance for spine procedures in September 2019. Edward Aulisi, MD, chair of neurosurgery at MedStar Washington Hospital Center, told WTOP that the hospital plans to add another Cirq robot soon. MedStar Georgetown University Hospital in Washington, D.C., also installed a Cirq arm in September. n

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