Stanford University researchers are seeking patent protection for a medical device for performing endovascular surgical procedures, such as thrombectomy, rotablation, drug delivery and treating brain aneurysms. The device includes a magnetically actuated untethered rotation device, i.e., a magnetic spinner, that can navigate in blood vessels through its spinning-enabled propulsion.
Surmodics Inc. is poised to jump on the market for below the knee thrombectomy now that its Pounce platform with a low-profile (LP) model has FDA 510(k) clearance. The system can now effectively clear organized clots from vessels as small as 2 mm in diameter. The Pounce LP expands the Eden Prairie, Minn.-based company’s “grab-go-flow” platform. In its first iteration, Pounce enabled removal of thrombi and emboli in peripheral arteries 3.5 mm to 6 mm in diameter.
Cardiovascular Systems Inc. (CSI) reported the submission by its partner Innova Vascular Inc. of U.S. FDA premarket notification for thrombectomy devices to treat peripheral vascular disease. Already an acknowledge leader in atherectomy technologies, St. Paul, Minn.-based CSI intends to acquire and commercialize each device to expand its technology portfolio to include treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE).
Imperative Care Inc. received U.S. FDA 510(k) clearance for its Zoom Rdl radial access system for treatment of ischemic strokes. The device is designed to enhance radial access for removal of clots in patients with tortuous anatomy and other challenges to the femoral access typically used, providing more options for both patients and physicians.
Cerenovus Inc. reported primary results from the real-world EXCELLENT Registry showing positive outcomes with its Embotrap revascularization devices in the removal of stroke-inducing blood clots. Patients enrolled in the registry were treated with either the Embotrap II or Embotrap III devices as a first line therapy to treat ischemic stroke.
Rapid Medical Inc. received FDA clearance for the Tigertriever 13, termed “the smallest and only adjustable thrombectomy device” for treating brain clots causing ischemic stroke. Stealing a page from aerospace engineers, Sunrise, Fla.-based Rapid Medical has developed complex, 3D “braiding” technology enabling its mechanical stent retriever to gain better access to and treat deeply embedded brain clots.
Vena Medical Inc. received Health Canada approval for a device that combines two neurovascular catheters that typically work separately to remove clots from the brains of people who have suffered stroke.
LONDON – Brainomix Ltd. has raised £16 million (US$ 21.2 million) in a series B, enabling the company to extend its artificial intelligence (AI)-driven diagnostic platform beyond the initial deployment in stroke, to the assessment of disease progression in lung fibrosis, and response to therapy in lung cancer.
Boston Scientific Corp. grabbed the remaining shares of Devoro Medical Inc. and its Wolf thrombectomy platform in a transaction valued at $269 million. Freemont, Calif.-based Devoro stands to gain an additional $67 million if the company achieves undisclosed clinical and regulatory milestones. Boston Scientific began investing in Devoro in 2019 and currently holds 16% of Devoro. The deal, the Marlborough, Mass.-based company’s fourth major transaction since the start of the second quarter, is expected to close by the end of the year. It follows the acquisitions of Preventice Solutions Inc., of Rochester, Minn., for $1.225 billion in April, which added to the company’s cardiac wearables, and Menlo Park, Calif.-based Farapulse Inc. for $295 million in June, to build out its cardiac ablation position. Boston Scientific purchased Yokneam, Israel-based Lumenis Ltd. for $1.07 billion, in a transaction that just closed three weeks ago.
Surmodics Inc. has acquired Vetex Medical Ltd., a Galway, Ireland-based company focused on venous clot removal, for $39.9 million. The move gives Surmodics a second FDA-cleared mechanical thrombectomy device, Revene, to treat venous vasculature, adding to its Pounce arterial thrombus retrieval system. Founded in 2016, privately held Vetex’s sole product is the Revene thrombectomy catheter. The device received FDA clearance in December 2020 and CE mark approval in May for the mechanical declotting and controlled and selected infusion of physician-specified fluids, including thrombolytics – clot-busting drugs – in the peripheral vasculature.
