CAMPBELL, Calif.–(BUSINESS WIRE)–Imperative Care, Inc. today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of the 82cm version of its Symphony™ 16F Catheter, the company’s latest innovation designed to elevate care for patients with venous thrombosis, a serious condition caused by a blood clot forming in the veins of the legs or abdomen that can have a life-threatening impact if left untreated.
“Thrombectomy procedures have emerged as one of the most powerful treatments in medicine, restoring vital blood flow in minutes. Historically, peripheral vascular thrombectomy has lacked technologies that effectively address challenging clot and preserve vessel health for the patient,” said Doug Boyd, SVP and General Manager of Imperative Care’s Vascular business. “Imperative Care set out to transform vascular care through purpose-built precision thrombectomy technologies that combine large-bore power with a precisely controlled deep vacuum within the sterile field, along with a focus on minimizing blood loss. The Symphony Thrombectomy System has introduced precision thrombectomy to the market, and we are confident it will deliver faster, safer and more precise clot removal that will ultimately benefit patients impacted by devastating vascular diseases.”
Initial Cases Using the Symphony™ 16F 82cm Catheter
The company also announced the successful completion of initial patient cases using the Symphony 16F 82cm catheter. Several of the initial cases were completed by Dr. Bennet George, Interventional Cardiologist at Vital Heart & Vein in Houston, Texas.
“In my early experience, I’ve been able to consistently achieve 97% clot removal in, on average, two passes, with minimal blood loss (<120ml) in less than ten minutes. With a large bore catheter and powerful deep vacuum, Symphony allows me to effectively treat highly challenging clot morphologies in minutes and in a blood-efficient way, ensuring the best possible outcomes for my patients,” said Dr. George. “The customized length of the 16F 82cm catheter gives me an additional capability to address both acute and organized clot in my venous procedures, and I look forward to its continued impact on the patients we treat.”
This latest innovation expands the Symphony Thrombectomy System offering to include 16F 82cm, 16F 117cm and 24F 85cm catheters.
Symphony has an integrated controller that delivers nearly three times the clot removal force compared to legacy aspiration systems1. Additionally, the system includes the ProHelix™ Mechanical Assist, a unique tool designed to facilitate clot ingestion, along with the Imperative Care Generator, the most powerful aspiration pump available on the market.
“At Imperative Care, we have always started by looking at critical unmet needs across the patient journey and working with a connected-care mindset to purposefully engineer solutions that put patients in the best position to live full and independent lives,” said Fred Khosravi, Chairman and CEO of Imperative Care. “With this latest offering and the enabling innovations in development at Imperative Care, we are poised to further advance the paradigm of care and provide physicians with the technologies that allow them to swiftly address these urgent ischemic diseases and best care for their patients.”
About the Symphony Thrombectomy System
The 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 loss1 and reducing case time. 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.
Contacts
Investor Contact:
Phil Nalbone, Vice President of Corporate Development and Investor Relations
Imperative Care, Inc.
pnalbone@imperativecare.com
Media Contact:
Hannah Kleinberg
Imperative Care, Inc.
707-326-0870
hkleinberg@imperativecare.com
