Surgical Robotics Technology

AngioDynamics gets Greenlight from FDA for PRESERVE Study

angiodynamics

AngioDynamics, a leading provider of innovative, minimally invasive medical devices for vascular access, peripheral vascular disease, and oncology, has received approval from the U.S. Food & Drug Administration (FDA) for the Pivotal Study of the NanoKnife System for Ablation of Prostate Tissue in an Intermediate-Risk Patient Population (PRESERVE).

The PRESERVE Study, initiated by AngioDynamics in partnership with the Society of Urologic Oncology Clinical Trials Consortium, Inc. (SUO-CTC), will evaluate the use of the NanoKnife System as a focal therapy option for prostate cancer patients, and assess the System’s safety and effectiveness when used to ablate prostate tissue in intermediate-risk patients. Full patient and provider information on the PRESERVE Study are available at clinicaltrials.gov.

The study will be led by Co-Principal Investigators Jonathan Coleman, MD, Urologic Surgeon, Memorial Sloan Kettering Cancer Center, and Arvin George, MD, Urologic Surgeon, University of Michigan. The PRESERVE Study will have its primary endpoint analysis at 12 months following initial treatment. “We are excited to be leading this multi-center trial,” said Dr. Coleman. “We anticipate the results of this study will provide valuable evidence to determine the appropriate use of focal therapy in intermediate-risk prostate cancer patients.”

“The PRESERVE Study represents a step forward in AngioDynamics’ investment to develop additional clinical pathways for the NanoKnife System,” said Juan Carlos Serna, SVP of Clinical and Scientific Affairs. “It is our hope that results from the PRESERVE Study will demonstrate NanoKnife System’s ability to provide a treatment option for patients with intermediate-risk prostate cancer in the United States.”

Approval of the study was originally announced during AngioDynamics’ Investor & Technology Day virtual event on July 13, 2021. More details about the PRESERVE Study from the virtual event can be accessed at https://bit.ly/ANGOInvestorDay (NanoKnife System and study information begins approximately 1 hour, 34 minutes into the recording).

The NanoKnife System utilizes Irreversible Electroporation (IRE) technology to effectively destroy targeted tissue, delivering precise treatment margins while preserving vital structures by retaining the structural integrity of the targeted tissue. , The delivery of non-thermal energy allows for the preservation of the extra-cellular matrix, facilitating post-ablation histological and functional tissue regeneration. To learn more and view risk information, visit NanoKnife.com.

In 2021, the American Cancer Society estimates that there will be about 248,530 new cases of prostate cancer and about 34,130 deaths from prostate cancer in the U.S. It is estimated that 1 out of every 8 men will be diagnosed with prostate cancer during his lifetime. It is the second leading cause of death in American men.

1Scheltema MJ, Chang JI, van den Bos W, Gielchinsky I, Nguyen TV, Reijke TM, Siriwardana AR, Böhm M, de la Rosette JJ, Stricker PD. Impact on genitourinary function and quality of life following focal irreversible electroporation of different prostate segments. Diagn Interv Radiol. 2018 Sep;24(5):268-275. doi: 10.5152/dir.2018.17374. PMID: 30211680; PMCID: PMC6135060.
2Li W, Fan Q, Ji Z, Qiu X, Li Z. The effects of irreversible electroporation (IRE) on nerves. PLoS One. 2011 Apr 14;6(4):e18831. doi: 10.1371/journal.pone.0018831. PMID: 21533143; PMCID: PMC3077412.
3Key Statistics for Prostate Cancer | Prostate Cancer Facts. Cancer.org. https://www.cancer.org/cancer/prostate-cancer/about/key-statistics.html. Published 2021. Accessed July 6, 2021.

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