KALAMAZOO—The medical device maker Stryker Corp. announced the launch of its Surpass Evolve Flow Diverter following approval by the U.S. Food and Drug Administration.
The device is the first 64-wire cobalt chromium flow diverter in the United States designed to re-direct blood flow and promote aneurysm healing. Surpass Evolve is Stryker’s latest innovation in flow diversion and follows the launch of Surpass Streamline in late 2018.
Since its launch in Europe last year, Surpass Evolve has been approved in over 45 countries and more than 1,500 patients have been treated with this life-saving technology. Physicians in these countries have confirmed the device as easier to use than its predecessor, offering effortless delivery, predictable deployment and implant opening, and excellent vessel wall apposition.
Mark Paul, president of Stryker’s Neurovascular division, added, “Surpass Evolve is our fourth PMA approval and second flow diverter approved by the FDA in the last two years. It augments our robust hemorrhagic portfolio and reflects our ongoing commitment to invest in technologies that will drive improved patient outcomes. Stryker is dedicated to working with our customers to bring life-saving technologies to patients suffering from brain aneurysms.”
An aneurysm occurs when part of a blood vessel becomes weak, causing the vessel to balloon or bulge and fill with blood. Aneurysms can occur in any blood vessel in the body. However, brain aneurysms are the most life-threatening. If left untreated, the aneurysm may continue to weaken until it bursts and bleeds into the brain. Almost 500,000 deaths occur each year as a result of a brain aneurysm.
Stryker offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine business units that help improve patient and hospital outcomes. More information is available at www.stryker.com.
Important safety information for the Surpass Evolve Flow Diverter may be accessed here: www.strykerneurovascular.com/dfu.