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Imperative Care Announces Completion of Enrollment in the SYMPHONY-PE IDE Study for Treatment of Pulmonary Embolism

By: via Business Wire

Pivotal trial evaluates safety and efficacy of the Symphony Thrombectomy System for the removal of blood clots from the lungs

Imperative Care, Inc. today announced the completion of patient enrollment in its SYMPHONY-PE Study (NCT06062329), a pivotal Investigational Device Exemption (IDE) trial evaluating the safety and efficacy of the company’s Symphony Thrombectomy System for the treatment of acute pulmonary embolism (PE), a life-threatening condition caused by blood clots blocking an artery in the lungs.

Designed to expand Symphony’s current indication for use to include PE, the study was conducted at 19 leading interventional radiology, interventional cardiology and vascular surgery centers across the United States.

“While progress has been made in the treatment of pulmonary embolism, there is still a need for therapies that may offer improvements in safety, efficiency and long-term patient outcomes,” said Dr. Vivian L. Bishay, M.D., Associate Professor in the Department of Diagnostic, Molecular and Interventional Radiology at Mount Sinai Health System in New York and National Co-Principal Investigator of the SYMPHONY-PE Study. “This study represents a promising step forward in evaluating next generation technology to expand treatment options for physicians and their patients.”

“Early clinical use of Symphony – including both 16F and 24F catheters – has shown promising potential for fast, safe and efficient clot removal for PE1 utilizing powerful precision thrombectomy,” said Dr. Sripal Bangalore, M.D., M.H.A., Professor in the Department of Medicine at NYU Grossman School of Medicine in New York and National Co-Principal Investigator of the SYMPHONY-PE Study. “We thank the patients, investigators, and clinical research teams whose efforts were instrumental in helping us complete enrollment. We look forward to sharing topline results later this year.”

“Initial experience with the novel Symphony Thrombectomy System at our center has been promising,” said Dr. Dana Tomalty, M.D., Peripheral and Neuro Interventional Radiologist at Huntsville Hospital in Alabama and the Site Principal Investigator. “I believe the study data may offer further insight into Symphony’s potential to transform the treatment of patients with PE.”

“At Imperative Care, our mission to elevate thrombectomy care is rooted in a commitment to validating our innovations with robust clinical data to ensure we are engineering solutions that make a measurable impact on patient outcomes,” said Fred Khosravi, CEO of Imperative Care. “Symphony is a critically important technology that is poised to transform treatment for patients with devastating pulmonary embolisms, a major cause of global morbidity and mortality. We greatly appreciate the investigators, clinical sites, and patients who have participated in this trial.”

Additional information about the trial, including eligibility criteria and a list of clinical trial sites, can be found at https://clinicaltrials.gov/.

About the Symphony Thrombectomy System

The currently cleared Symphony Thrombectomy System is a large-bore aspiration catheter system designed to enable more efficient and effective thrombectomy procedures in patients with venous thrombosis. Combining large-bore power with precise deep vacuum in the sterile field, Symphony delivers maximum clot removal while minimizing blood loss and reducing case time1. The system consists of three Symphony Catheters, including the largest commercially available aspiration catheter, which are integrated with a controller all from the palm of the physician’s hand. Additionally, the system includes the ProHelix™ Mechanical Assist, the Imperative Care Generator and other accessories. 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 researching and developing connected innovations to elevate care for people affected by devastating vascular diseases such as stroke and pulmonary embolism. The company is focused on addressing specific gaps in treatment and care to make an impact across the entire patient journey. Imperative Care is based in Campbell, Calif. https://imperativecare.com.

1 Data on file

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