Surpass Evolve Flow Diverter Designed to Treat Brain Aneurysms Launches

Surpass Evolve Flow Diverter has been launched by Stryker, following approval by the U.S. Food and Drug Administration.

Surpass Evolve Flow Diverter is the first 64-wire cobalt chromium flow diverter in the U.S. 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.

“This device builds on the success of Surpass Streamline, offering a highly optimized and easy to use flow diverter. By increasing the braid angle, the novel 64-wire device delivers excellent flow diversion and a highly flexible implant for enhanced vessel wall contact.  The higher mesh density of Surpass Evolve versus traditional 48-wire flow diverters may lead to faster aneurysm occlusion for patients,” said Dr. Ajay Wakhloo, a pioneer of flow diversion and the first physician to complete a commercial case in the U.S.

Since its launch in Europe last year, Surpass Evolve Flow Diverter 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. The arrival of Surpass Evolve has been highly anticipated in the U.S. due to these impressive technical and clinical results.

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.”

SourceStryker

Hot this week

Cartessa Aesthetics Partners with Classys to Bring EVERESSE to the U.S. Market

Classys, which is listed on the KOSDAQ, is one of South Korea's most distinguished aesthetic technology manufacturers, with devices distributed in 80+ markets globally. This partnership marks Classys's official entry into the American marketplace, with Cartessa Aesthetics as the exclusive distributor for EVERESSE, launched under the Volnewmer brand in current global markets.

Stryker Launches Next-Generation of SurgiCount+

Now integrated with Stryker's Triton technology, SurgiCount+ addresses two key challenges: retained surgical sponges and blood loss assessment. Integrating these previously separate digital solutions provides the added benefit of a more efficient, streamlined workflow for hospitals notes Stryker.

Nevro Receives CE Mark In Europe for It’s HFX iQ™ Spinal Cord Stimulation System

Nevro notes HFX iQ is the first and only SCS system with artificial intelligence (AI) technology that combines high-frequency (10 kHz) therapy built on landmark evidence that uses ongoing cloud data insights to deliver personalized pain relief

Recor Medical Reports: CMS Grants Distinct TPT Device Code and Category to Recor Medical for Ultrasound Renal Denervation

The approval of TPT offers incremental reimbursement payments for outpatient procedures performed with ultrasound renal denervation for Medicare fee-for-service beneficiaries. It becomes effective January 1, 2025, and is expected to remain effective for up to three years notes Recor Medical.

Jupiter Endovascular Reports | 1st U.S. Patient Treated with Jupiter Shape-shifting Thrombectomy Device

“Navigation challenges during endovascular procedures are often underappreciated and have led to under-adoption of life-saving procedures, such as pulmonary embolectomy. We have purpose-built our Endoportal Control technology to solve these issues and make important endovascular procedures accessible to more clinicians and their patients who can benefit from them,” said Carl J. St. Bernard, Jupiter Endovascular CEO. “This first case in the U.S. could not have gone better, and appears to validate the safety and performance we are seeing in our currently-enrolling European SPIRARE I study.”