Imperative Care’s SYMPHONY-PE Study Enrollment Ends

Imperative Care Inc. has completed patient enrollment in its SYMPHONY-PE Study, a pivotal Investigational Device Exemption (IDE) trial intended to expand use of the Symphony Thrombectomy System to include acute pulmonary embolism (PE).

“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, N.Y., and SYMPHONY-PE national co-principal investigator. “This study represents a promising step forward in evaluating next generation technology to expand treatment options for physicians and their patients.”

Evaluating the Symphony Thrombectomy System’s safety and efficacy, the SYMPHONY-PE trial was conducted at 19 U.S. interventional radiology, interventional cardiology and vascular surgery centers. Acute pulmonary embolism is a life-threatening condition caused by blood clots blocking an artery in the lungs.

“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., professor in the Department of Medicine at NYU Grossman School of Medicine in New York, N.Y., and SYMPHONY-PE national co-principal investigator. “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.”

The currently cleared Symphony Thrombectomy System is a large-bore aspiration catheter system that enables 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 time.¹ The system consists of three Symphony Catheters, including the largest commercially available aspiration catheter, which are integrated with a controller held by the physician. Additionally, the system includes the ProHelix Mechanical Assist, the Imperative Care Generator, and other accessories.

“Initial experience with the novel Symphony Thrombectomy System at our center has been promising,” commented 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,” Imperative Care CEO Fred Khosravi stated. “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.”

Imperative Care is researching and developing connected innovations to elevate care for people affected by vascular diseases such as stroke and pulmonary embolism. The Campbell, Calif.-based company is focused on addressing specific treatment and care gaps to help improve the patient journey.

Reference
¹ Data on file