Aortic Aneurysm, Abdominal

The recall covers Medtronic Neurosurgery’s Duet external drainage and monitoring system, designed for short-term unloading of CSF through the skull or lumbar puncture sites. The FDA has handed down a Class I label, the agency’s most serious, to a Medtronic recall of medical tubing used to drain a patient’s cerebrospinal fluid. The recall spans more than 45,000 equipment sets distributed in the U.S. from May 2021 through January of this year, when the medtech giant alerted healthcare providers to a potential issue where its Duet collection catheters could disconnect from the patient’s fluid line. According to the FDA, the resulting leak could lead to a dangerous loss of cerebrospinal fluid as well as carry the potential to introduce infections into the nervous system. The agency said it had received 26 reports of related injuries but no reports of death. The recall covers Medtronic Neurosurgery’s Duet external drainage and monitoring system, designed for short-term unloading of the skull or lumbar puncture sites, as well as sample collection. The closed system, also used internationally, relies on gravity to collect CSF or blood through a drip chamber. It is also employed in patients undergoing surgery to repair an abdominal aortic aneurysm and to absolve subsequent symptoms such as short-term lower paralysis.  Jan. 23, Medtronic sent customers a recall letter urging them to quarantine impacted products—including model numbers 46913, 46914, 46915, 46916 and 46917—and to return any unused equipment to the manufacturer. The company said any system currently being used with a patient should be left in place if it is working correctly; however, a recalled or leaking Duet system should be swapped out using a sterile technique and discarded.

SANTA CLARA, Calif.--(BUSINESS WIRE)-- Shape Memory Medical Inc., developer of custom shape memory polymers for endovascular markets, announced today that it has completed $38 million in Series C financing led by Earlybird Venture Capital and with the participation of new and existing investors, including HBM Healthcare Investments (Cayman) Ltd., WexMed II LLC, HBM-Medfocus LLC, and Emergent Medical Partners II, L.P.. “With this financing, we are well positioned to accelerate the clinical and market development of shape memory polymer technology for aortic and peripheral vascular markets,” said Ted Ruppel, president and CEO of Shape Memory Medical. “The funds will support the execution of the AAA-SHAPE Pivotal Trial, a randomized controlled study comparing EVAR plus sac management with IMPEDE-FX RapidFill to stand-alone EVAR. The funding will also support the research and development of our product pipeline, and the expansion of sales and marketing strategies to address the increasing demand for our commercially-available IMPEDE Embolization Plug family of devices,” continued Ruppel. The Company’s proprietary shape memory polymer is a low-density, porous embolic material that is crimped for catheter delivery and self-expands upon contact with blood for rapid conversion to organized thrombus. The technology offers unique properties including vascular space-filling, radiolucency, low radial force, and stimulation of the immune response and healing system. The company recently announced that the Food and Drug Administration (FDA) granted investigational device exemption (IDE) for the company to begin a prospective, multicenter, randomized, open-label trial to determine the safety and effectiveness of the IMPEDE-FX RapidFill® Device in improving abdominal aortic aneurysm (AAA) sac behavior, when used with elective endovascular aneurysm repair (EVAR). Thom Rasche, Partner at Earlybird Venture Capital and the newest addition to the Shape Memory Medical Board commented, “Shape Memory Medical’s approach to embolization is highly differentiated. At Earlybird Health, we support companies with breakthrough technologies and robust, positive patient outcomes. With 35 million people worldwide affected by AAA, leading to 150,000-200,000 annual deaths due to rupture, Shape Memory Medical’s innovative concepts for managing aortic aneurysms have the potential to be transformative in treating this condition.” About Shape Memory Medical Shape Memory Medical Inc. is dedicated to developing innovative therapeutic solutions with its proprietary shape memory polymers, with devices approved in more than 25 countries spanning regions in Asia, the Middle East, Europe, the Americas and Australia. Neurovascular embolization products include the TrelliX® Embolic Coil, which is CE marked for use in the EU. Peripheral embolization products include the IMPEDE® and IMPEDE-FX Embolization Plugs and IMPEDE-FX RapidFill® Device. In countries recognizing CE marking, the IMPEDE and IMPEDE-FX Embolization Plugs and the IMPEDE-FX RapidFill are indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature. In the United States, the IMPEDE Embolization Plug is indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature, and the IMPEDE-FX Embolization Plug is indicated for use with the IMPEDE Embolization Plug to obstruct or reduce the rate of blood flow in the peripheral vasculature. The IMPEDE and IMPEDE-FX Embolization Plugs are PMDA approved in Japan. Caution: IMPEDE-FX RapidFill is an investigational device, limited by Federal (or United States) law to investigational use. For more information, visit . About Earlybird Venture Capital Earlybird Venture Capital focuses on European technology companies. Founded in 1997, Earlybird identifies and backs exceptional early-stage companies on a pan-European basis and supports them through their growth and development phases – providing financial resources, strategic support, plus access to an international network and capital markets. Earlybird invests out of a family of independently-managed funds. Flagship funds with early-stage focus include Digital West (Western Europe), Digital East (Emerging Europe), and Health. Newer funds Earlybird-X (pre-seed in Western Europe & university spinoffs) and Growth Opportunities (a pan-Earlybird growth fund) offer even more agility. With EUR 2 billion under management across all fund streams, 9 IPOs, and 32 trade sales, Earlybird is one of Europe’s most established and active venture capital firms. More information on , LinkedIn and X.

IRVINE, Calif.--( BUSINESS WIRE )-- Endologix LLC , a privately held, global medical device company dedicated to providing disruptive therapies for the interventional treatment of vascular disease, announced today the initiation of the PTAB1 Post-Market Study. This study marks the beginning of a comprehensive post-market study aimed at evaluating the real-world performance of the DETOUR System in patients undergoing treatment for long complex superficial femoral artery (SFA) disease. The study will leverage the Vascular Quality Initiative (VQI) registry infrastructure developed and supported by the Society for Vascular Surgery Patient Safety Organization (SVS PSO). The PTAB1 Post-Market Study evaluates the DETOUR System's performance in patients with very long (TASC D) SFA lesions. The study plans to enroll up to 450 subjects, with a focus on including at least 200 women and also features an imaging sub study. Recruitment will involve up to 200 sites, with five-year follow-up. “The initiation of the PTAB1 Post-Market Study represents a pivotal moment in our ongoing commitment to advance the treatment of complex peripheral arterial disease. Through this study, we aim to further validate the DETOUR System's innovative approach to overcoming complex PAD challenges," expressed Matt Thompson, MD, President, and CEO of Endologix. Dr. Thomas S. Maldonado, the Schwartz-Buckley Endowed Professor of Surgery in the Vascular Division at New York University Langone Medical Center, underscored the significance of being the inaugural site to enroll a PTAB patient. "Our privilege of enrolling the first patient in the PTAB1 Post-Market Study underscores our commitment to advancing patient care in complex PAD. The DETOUR System offers a glimpse into a future where minimally invasive treatments could redefine our approach to extensive SFA lesions. We are optimistic about the contributions this study will make towards evolving patient treatment paradigms." About the DETOUR System PTAB with the DETOUR System offers a novel approach to treating complex PAD, enabling physicians to bypass lesions in the superficial femoral artery, by using stents routed through the femoral vein via a transmural passage, to restore blood flow to the leg. This approach is effective for patients with long lesions (20cm-46cm in length), those that have already undergone failed endovascular procedures, or those that may be sub-optimal candidates for open surgical bypass. About Endologix Endologix LLC is a California-based, global medical device company dedicated to improving patients’ lives by providing innovative therapies for the interventional treatment of vascular disease. Endologix’s therapeutic portfolio includes a variety of products in various stages of development that are designed to treat diseases that currently have clinically relevant unmet needs. Endologix's commercial products, including the AFX®2 Endovascular AAA System, ALTO® Abdominal Stent Graft System, and the DETOUR TM System, are designed to treat a range of vascular diseases, from abdominal aortic aneurysms to lower limb peripheral vascular disease. Endologix is wholly owned by Deerfield Management, an investment management firm committed to advancing healthcare through investment, information, and philanthropy. The company has offices and manufacturing sites in Irvine, Milpitas and Santa Rosa, California. To learn more about Endologix, please visit https://www.endologix.com/ . About SVS VQI The Society for Vascular Surgery® Vascular Quality Initiative® (SVS VQI) clinical registry is governed by the SVS Patient Safety Organization (SVS PSO), a wholly owned subsidiary of the Society for Vascular Surgery, which provides oversight of data sharing arrangements, key outcome and quality measure analyses, and dissemination of information to participating providers. SVS VQI comprises vascular surgeons, cardiac surgeons, general surgeons, cardiologists, radiologists, and other specialists who perform vascular procedures collected in the VQI Registries, as well as Quality Improvement professionals, data managers and others dedicated to improving patient outcomes. Over 1,000 participating centers are divided into 18 regional quality groups who meet biannually to discuss initiatives for improving the quality of vascular care. SVS VQI is powered by the Fivos cloud-based registry platform. To learn more about SVS VQI, please visit www.vqi.org [vqi.org] .