Data from First Phase of DEXTERITY-AFP Study Unveiled at VEINS Meeting in Las Vegas
LAS VEGAS, NV / ACCESSWIRE / October 30, 2023 / The DEXTERITY-AFP study, led by vascular surgeon Dr. David Dexter and interventional radiologist Dr. Mahmood Razavi, reached a significant milestone with the release of data from its first phase during the Late Breaking Trials session at the annual VEINS meeting in Las Vegas today. Dr. Dexter, on behalf of the DEXTERITY-AFP study investigators, presented compelling findings that have the potential to reshape deep vein thrombosis (DVT) therapy in patients who have exhibited symptoms for less than 14 days (the acute phase). Dr. Dexter, the worldwide co-Principal Investigator of the study, expressed his enthusiasm for the promising results, stating, “We are delighted to announce that the data from the initial phase of the DEXTERITY-AFP study has exceeded our expectations. These findings are a positive step forward in the treatment of DVT, and we are excited to move into the randomized controlled trial (RCT) phase, which marks a pivotal moment in our quest to improve DVT therapy.”
The DEXTERITY-AFP study, a multi-year, multi-center research initiative sponsored by Mercator MedSystems, Inc., aims to reduce local venous inflammation that occurs with DVT. While current therapies are geared toward removing the blockage and restoring blood flow, they do not address the underlying inflammation that leads to scarring and vein stiffening, which often produce chronic negative symptoms collectively known as post-thrombotic syndrome (PTS). In the study, the Mercator Bullfrog® Micro-Infusion device is used to locally deliver a common anti-inflammatory drug, dexamethasone, into the outer lining of veins deep in the leg in an attempt to prevent scarring and venous dysfunction and reduce the chronic symptoms associated with PTS. Based on the 6-month data presented in the VEINS meeting, the symptom scores in patients treated with perivascular dexamethasone were meaningfully improved in comparison to what has been published in similar large-scale trials of acute DVT treatments with thrombus removal alone.
This first phase of the study has yielded critical insights, laying the foundation for further exploration. Kirk Seward, PhD, President and Chief Science and Technology Officer of Mercator MedSystems, also expressed his thoughts on the groundbreaking data. “The data presented today marks a significant advancement in the field of DVT therapy,” said Dr. Seward. “This accomplishment underlines our commitment to improving the lives of patients with DVT and reflects the dedication of the entire scientific community toward treatments that have the capability to significantly improve patients’ lives after DVT therapy. The collaboration between physician leaders including Dr. Dexter, Dr. Razavi, and Mercator has been instrumental in bringing us to this moment.”
The DEXTERITY-AFP study is poised to drive innovation in the treatment of DVT, offering new hope for patients worldwide. The study has officially received positive feedback from a data safety monitoring board and has now entered the RCT phase with the enrollment of its first patient. With the move into this larger study, anticipation and excitement continue to build, holding promise for better therapies for those affected by this debilitating condition.
About the Bullfrog® Micro-Infusion Device
The Bullfrog® and LeapfrogTM Micro-Infusion Devices are FDA cleared and CE marked. These devices include a balloon that hydraulically deploys a micro-needle through the vessel wall into perivascular tissues, where the needle can then efficiently infuse drugs or biologics around an artery or vein. Drug delivery through either device is tracked with X-ray contrast agents, allowing precision therapy to local tissues with visual feedback to the physician using the device.
About Mercator MedSystems, Inc.
Mercator is a medical technology company focused on the clinical and commercial development of proprietary, FDA-cleared and CE-marked catheter-based micro-infusion technologies, including the Bullfrog® and LeapfrogTM Micro-Infusion Devices for the local delivery of therapeutics in blood vessels and the Blowfish® Transbronchial Micro-Infusion Catheter for delivery in airways. Mercator is developing clinical applications in peripheral vascular disease, cancer, hypertension and cardiac regeneration. For further information, please visit https://mercatormed.com.
Trent Reutiman Chief Executive Officer Mercator MedSystems, Inc. 520 McCormick Street San Leandro, CA 94577 Phone: +1.510.564.7757 E-mail: firstname.lastname@example.org
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