Company Announces First Patient Enrolled in CLEAR-IT Study Evaluating Symphony and Prodigy Thrombectomy Systems for Vascular Disease
CAMPBELL, Calif.--(BUSINESS WIRE)--Imperative Care, Inc., a medical technology company focused on advancing treatments for patients suffering from thromboembolic disease, today announced the enrollment of the first patient in the CLEAR-IT Study, a prospective, observational clinical study evaluating the performance of its Symphony® and Prodigy® Thrombectomy Systems. This study aims to advance the development of meaningful clinical standards for the treatment of peripheral thromboembolic diseases.
“The CLEAR-IT Study underscores Imperative Care’s commitment to advancing meaningful innovation grounded in rigorous clinical science to improve patient outcomes and address the unmet needs in peripheral thromboembolism,” said Emir Deljkich, Senior Vice President of Clinical Affairs. “Just as robust clinical data from the Imperative Trial has helped establish new standards of care in acute ischemic stroke, we believe the same level of scientific rigor is essential to advance the peripheral thromboembolism space. This study represents a critical step in building clinical evidence to support large-bore, vacuum-generated aspiration thrombectomy for venous thromboembolism, as well as the evaluation of novel device designs for arterial thromboembolism.”
Peripheral thromboembolic conditions, including pulmonary embolism (PE), peripheral venous thrombosis, and peripheral arterial thrombosis, can pose serious risks for patients and often require endovascular thrombectomy. The Symphony and Prodigy Thrombectomy Systems are aspiration-based technologies used in endovascular thrombectomy procedures across the peripheral and pulmonary vasculature, designed to give physicians greater control to remove more clot in less time while minimizing blood loss.
The CLEAR-IT Study (Long-Term CLinical Evaluation of Aspiration ThRombectomy Using the Symphony or ProdIgy Thrombectomy Systems) is expected to enroll up to 750 patients across up to 50 sites in the United States to evaluate the short- and long-term clinical performance and safety of Symphony and Prodigy. By assessing outcomes in PE, peripheral venous thrombosis, and peripheral arterial thrombosis, the study will evaluate procedural characteristics and patient outcomes in a real-world setting, with the goal of contributing evidence to inform the development of clinical standards for the treatment of these conditions. The study is co-led by Steven Abramowitz, M.D., Chief of Vascular Surgery at MedStar Hospital, Washington DC, and Dr. Maya Serhal, M.D., an interventional cardiologist and vascular interventionalist at Massachusetts General Hospital.
“CLEAR-IT is designed to evaluate how Symphony and Prodigy perform across a broad range of peripheral thromboembolic conditions in real-world clinical practice,” said Dr. Abramowitz. “This study is structured to drive clinically meaningful endpoints that matter to physicians and patients. By generating high-quality data across multiple disease states, we believe the CLEAR-IT study can move the field closer to establishing clear clinical standards for the treatment of each of these respective diseases.”
The first patient enrolled in the study was treated by Dana Tomalty, M.D., of Huntsville Hospital Health System in Huntsville, Alabama, who serves as the site’s Principal Investigator.
“Following the SYMPHONY-PE investigational device exemption trial, which demonstrated favorable safety and efficacy results, initial real-world experience with this technology has shown fast, effective clot removal with minimal blood loss,” said Dr. Tomalty. “We look forward to contributing to independently adjudicated clinical data that have the potential to further advance the field and support more informed clinical decision-making for patients with thromboembolic disease.”
About the Symphony Thrombectomy System
The Symphony Thrombectomy System is a large-bore aspiration system engineered to deliver more efficient and effective clot removal in patients with venous thromboembolism (VTE). Symphony is designed to combine large-bore power with precise deep vacuum to provide physicians greater control to remove more clot in less time. By delivering deep vacuum closer to the clot, Symphony generates a Deep Pulse, a powerful pulse of aspiration intended to increase clot removal force compared to a tubing-based system,1 while minimizing blood loss.2 The system includes 16F and 24F catheters for smooth tracking, stability, and telescoping to reach distal anatomy; ProHelix® Mechanical Assist designed to facilitate clot ingestion when needed; the Symphony 24F Advance® Long Dilator for navigating through tortuous anatomy; and the Imperative Care Generator, a powerful aspiration pump.
For complete product information, including indications, contraindications, warnings, precautions and adverse events, visit: http://bit.ly/3pAaUlw.
About the Prodigy Thrombectomy System
The Prodigy Thrombectomy System is a small-bore aspiration system designed to bring greater clarity, control and consistency to arterial thrombectomy. Through the Gauge, a multifunctional visual chamber, Prodigy aims to provide physicians with clear, actionable insights to simplify workflows, reduce device time and minimize blood loss. Prodigy is used to treat a wide range of anatomies in both the upper and lower extremities across varying clot morphologies. The system includes four catheter sizes (5F, 6F, 8F, 8F-S) that leverage Imperative Care’s asymmetric tip design; the Prodigy® Twist designed to streamline clot ingestion without upsizing the catheter; and the Imperative Care Generator, a powerful aspiration pump.
For complete product information, including indications, contraindications, warnings, precautions and adverse events, visit: http://bit.ly/3pAaUlw.
About Imperative Care, Inc.
Imperative Care is a commercial-stage medical technology company focused on advancing treatments for patients suffering from thromboembolic disease, a serious medical condition caused by blood clot formation inside veins and arteries. Imperative Care was founded with the mission of bringing lifesaving treatments to patients suffering from ischemic stroke and other devastating vascular diseases caused by blood clot formation. The company’s commercially available product portfolio includes the Zoom Stroke System, the Symphony Thrombectomy System and the Prodigy Thrombectomy System. In addition to our commercial products, we are developing the Telos robotic platform*, an endovascular robotic system designed to bring greater precision and standardization to procedures and expand access to lifesaving treatment. Imperative Care is based in Campbell, Calif. https://imperativecare.com.
- Data on file at Imperative Care
- Data from SYMPHONY-PE IDE Trial
Dr. Dana Tomalty and Dr. Steven Abramowitz are paid consultants for Imperative Care.
*Currently in development. Not approved for use or available for sale.
Contacts
Media Contact:
Lara Lingenbrink
Imperative Care, Inc.
858-525-1414
llingenbrink@imperativecare.com
Investor Contact:
Phil Nalbone
Imperative Care, Inc.
pnalbone@imperativecare.com
