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CLINICAL TRIALS, STUDIES, REGISTRIES, DATA

Clinical trials, studies, data, and updates reported in Medical Device News Magazine.

Thubrikar Aortic Valve Announces Authorization to Expand the TAVI-1 CE Mark Trial with the Precision 2 Delivery Catheter

The Precision 2 Catheter is engineered to provide operators with significant control. It allows the Optimum TAV to be repositioned and recaptured for retrieval, if necessary, during the TAVI procedure. Due to the innovative catheter design, the Optimum TAV’s short frame reorients as it is deployed in the diseased valve which results in automatic axial alignment of the valve. The Company’s Medical Advisors, Dr. Susheel Kodali, Director of the Structural Heart & Valve Center at New York-Presbyterian/Columbia University Medical Center, and Dr. Mathew Williams, Director of the Heart Valve Center at NYU Langone Health, provided guidance on the development of the new catheter.

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New Clinical Study Highlights Efficiency in Spine Surgery of NextAR Spine, Augmented Reality Surgical Application

The study “Evaluating a cutting‑edge augmented reality‑supported navigation system for spinal instrumentation”1 led by Prof. Dr. med. Bernhard Meyer, evaluates the efficiency, accuracy, and versatility of NextAR Spine, a navigation system that incorporates augmented reality to provide unique real-time surgical guidance, superimposed onto the operative field, enhancing precision and enabling data-driven decision-making in the placement of pedicle screws, and addressing different types of spine indications, such as trauma, degeneration, infection, and tumor.

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NeuroSense Therapeutics Reports New Data: Statistically Significant Clinical Efficacy in Phase 2b ALS Trial

“As we analyze the PARADIGM trial results, we continue to gain a better understanding of PrimeC’s potential to render a significant and meaningful clinical benefit to people living with ALS. Today we are eager to share these new data with the ALS community, as we believe the PP analysis, demonstrating a statistically significant 37.4% difference in ALSFRS-R in patients treated with PrimeC vs. placebo, is an exceptional result,” stated Alon Ben-Noon, NeuroSense Therapeutics CEO.  “This data, in conjunction with hopefully correlative neurofilament readouts, will create a regulatory opportunity to advance PrimeC’s development in a breakthrough manner toward the market.”

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Menarini Group Presented Initial Safety and Efficacy Data from Phase 1b/2 ELEVATE and ELECTRA Combination Studies of ORSERDU® (Elacestrant) in Patients with ER+, HER2- Metastatic Breast Cancer (mBC) at the 2023 San Antonio Breast Cancer Symposium

“It is encouraging to see positive initial safety results in various combination studies of ORSERDU, along with promising preliminary efficacy data in these trials,” said Hope Rugo, MD, professor of medicine, Division of Hematology and Oncology at the University of California San Francisco Helen Diller Family Comprehensive Cancer Center. “We look forward to learning more about ORSERDU’s role in combination settings and its potential across the spectrum of metastatic breast cancer.”

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AngioDynamics Completes Patient Enrollment in APEX-AV Study Assessing AlphaVac F1885 System in Treatment of Pulmonary Embolism

“The completion of the APEX-AV Study represents an important milestone in the catheter-directed therapies CDT space for the treatment of pulmonary embolism. I sincerely thank all the investigators for their commitment and dedication,” said William Brent Keeling, MD, Associate Professor of Surgery, Department of Surgery, at the Emory University School of Medicine, and Immediate Past President, The PERT Consortium™.

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