Occlusion of artery

Initial 20 Patients Enrolled in the First-in-Human Trial Had a 0% Rate of Reintervention. LOS ALTOS, Calif., April 23, 2025 /PRNewswire/ -- The initial long-term results from EFEMORAL I were presented today by Principal Investigator Prof. Andrew Holden (Auckland City Hospital, Auckland, New Zealand) at the Charing Cross Symposium in London, UK. EFEMORAL I is a first-in-human clinical trial evaluating the performance of the Efemoral Vascular Scaffold System (EVSS) for the treatment of patients suffering symptomatic peripheral arterial occlusive disease from atherosclerosis of the femoropopliteal artery. The results from the initial 20 patients enrolled across four sites in Australia and New Zealand were presented. The key findings included: Continue Reading Mean lesion length of 5.1 ± 2.0 mm 0 ± 15% post-procedure residual stenosis 0% acute/subacute thrombosis 0.41 ± 1.0 mm late lumen loss at 6 months (angiographic subset, n=10) 4.74 ± 0.86 mm mean minimal lumen diameter at 6 months (angiographic subset, n=10) Median follow-up of 2 years 100% primary patency at 3 years 100% freedom from target lesion revascularization at 3 years Sustained improvement in clinical outcome and walking tolerance at 3 years "The 0% post-procedure residual stenosis in EFEMORAL I is the lowest ever reported for a femoropopliteal trial." Post this "In this first patient experience, I found the EVSS to be simple to deploy and strong enough so that I can fully restore the original arterial lumen diameter at the time of the procedure. Furthermore, it elutes a relatively high dose of Sirolimus over several months, leading to excellent long-term outcomes, all without the need for a permanent implant," stated Prof. Holden. "I'm looking forward to expanding my use of this device in more patients with more complex lesions." The EVSS offers a new approach to treating peripheral arterial disease (PAD) by addressing the specific anatomical challenges and complex biomechanics of patients with athero-occlusive disease in the leg. Through the use of inter-scaffold spaces, the patented FlexStep Technology combines flexibility with support to accommodate tortuosity and skeletal movement, while the balloon-expandable deployment system easily opens vessels and sustains healthy blood flow. The novel bioresorbable scaffold with long-term Sirolimus elution aims to restore normal vessel diameter at the time of the procedure, deliver therapeutic benefits across all lesion lengths and morphologies, prevent restenosis, and maintain patency while leaving no permanent implant behind. "Compared to balloon angioplasty or self-expanding nitinol stents that are commonly used to treat patients with narrowing in their femoropopliteal artery, balloon expandable scaffolds with high radial strength, such as the EVSS, allow for a more complete expansion of the vessel at the index procedure," said Lewis B. Schwartz, MD, Co-Founder and CMO of Efemoral Medical. "A low residual stenosis means the lumen of the vessel has been restored to its original diameter and is a predictor of favorable long-term outcomes. The 0% post-procedure residual stenosis in EFEMORAL I is the lowest ever reported for a femoropopliteal trial, while the mean minimal lumen diameter of 4.74 mm at 6 months is the highest ever reported." "The EVSS represents a new paradigm in peripheral interventions," said Christopher Haig, Co-Founder and CEO of Efemoral Medical. "It's easy to deploy, has high radial strength, can be made in longer lengths, and offers the promise of durable outcomes without the need for a permanent implant." About Peripheral Arterial Disease (PAD) PAD, also known as "poor circulation" or "hardening of the arteries," is a global plague. Worldwide, it affects approximately 200 million people1, including an estimated 20 million people in the United States2. Left untreated, PAD can lead to severe disability and extremity amputation. The effectiveness of current interventional treatment remains limited, with up to 50% of conventional endovascular procedures complicated by failure or recurrence within the first year.3 About Efemoral Medical, Inc. Efemoral Medical, Inc. is developing next-generation bioresorbable solutions to treat patients with vascular disease. The company's initial product, the Efemoral Vascular Scaffold System (EVSS) with FlexStep Technology, is designed to offer a dedicated strategy for PAD interventions. The Efemoral Vascular Scaffold System (EVSS) is an OUS Investigational Device only. To learn more, please visit efemoralmedical.com. 1 2 Yost, The True Prevalence of PAD and the Economics of Major Amputation Endovascular Today, May 2021 3 SOURCE Efemoral Medical WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Now available in the U.S., the Shockwave Javelin Peripheral Intravascular Lithotripsy Catheter safely modifies and crosses occlusive or extremely narrowed calcific peripheral artery disease SANTA CLARA, Calif., March 4, 2025 /PRNewswire/ -- Today, Shockwave Medical, Inc., part of Johnson & Johnson MedTech and a global leader in the field of circulatory restoration, announced the U.S. launch of its Shockwave Javelin Peripheral IVL Catheter, a novel intravascular lithotripsy (IVL) platform designed to modify calcium and cross extremely narrowed vessels in patients with peripheral artery disease (PAD). The first-of-its-kind forward IVL platform has a similar safety and efficacy profile of legacy Shockwave IVL catheters and bolsters the company's market-leading IVL portfolio. Continue Reading Shockwave Javelin Peripheral IVL Catheter, a novel intravascular lithotripsy (IVL) platform designed to modify calcium and cross extremely narrowed vessels in patients with peripheral artery disease (PAD). PAD is the narrowing or blockage of the vessels that carry blood from the heart to the legs, reducing blood flow and affecting more than eight million people aged 40 and older in the U.S.1,2 People suffering from PAD have impaired quality of life and increased risk of heart attack or stroke.1 Chronic limb-threatening ischemia (CLTI) is the most advanced and serious form of PAD, impacting nearly two million patients in the U.S. It is associated with 40% major amputations at one year and a 50% mortality rate at five years, worse than most forms of cancer.3 "Physicians have faced significant challenges in tackling complex calcific lesions in narrowed peripheral vessels, and there is a growing need for more effective crossing and treatment tools," said JD Corl, M.D., FACC, FSCAI, Medical Director of the PAD/CLI Program at The Lindner Center for Research and Education at The Christ Hospital.† "With proven safety and effectiveness similar to existing IVL devices, Shockwave's new IVL platform will bring a transformative approach to our peripheral practices, enabling us to make cases more efficient and optimize outcomes for our patients living with PAD, especially those with more complex CLTI." The forward IVL platform is designed to modify calcium and cross calcified occlusive disease or extremely narrowed lesions where a wire will cross but devices might not. Shockwave Javelin has a working length of 150 centimeters and features a single distal emitter that creates up to 120 shockwave pulses. Each shockwave pulse creates a spherical energy field that extends beyond the tip of the catheter. This novel design delivers lithotripsy closer to calcium than the balloon-based platform. Despite the challenging nature of the calcified lesions studied, the clinical outcomes from the FORWARD PAD IDE trial demonstrated that Shockwave Javelin has a similar safety and effectiveness profile to balloon-based Shockwave IVL catheters. "As the pioneer of IVL technology, our goal is to continue to deliver innovations that address the unmet needs of the physicians that we serve," said Nick West, M.D., Chief Medical Officer, Shockwave Medical. "By listening to and leveraging their valuable insights, we developed our transformational forward IVL platform with the unique capability to both modify calcium and cross extremely narrowed vessels. We are proud to be leading the charge in offering endovascular interventionalists more flexibility to address critical treatment needs and potentially reduce the risks associated with CLTI for their patients." Combined with Shockwave E8, Shockwave L6, Shockwave M5+, and Shockwave S4 IVL catheters, the addition of the Shockwave Javelin Peripheral IVL catheter offers physicians a comprehensive IVL portfolio to treat challenging calcified lesions above and below the knee across the entire peripheral anatomy. About Shockwave Medical Shockwave Medical Inc., part of Johnson & Johnson MedTech, is a leader in the development and commercialization of innovative products that are transforming the treatment of cardiovascular disease. Its first-of-its-kind Intravascular Lithotripsy (IVL) technology has transformed the treatment of atherosclerotic cardiovascular disease by safely using sonic pressure waves to disrupt challenging calcified plaque, resulting in significantly improved patient outcomes. Its Reducer technology, which is under clinical investigation in the United States and is CE Marked in the European Union and the United Kingdom, is designed to provide relief to the millions of patients worldwide suffering from refractory angina by redistributing blood flow within the heart. Learn more at . Cardiovascular Solutions from Johnson & Johnson MedTech Across Johnson & Johnson, we are tackling the world's most complex and pervasive health challenges. Through a cardiovascular portfolio that provides healthcare professionals with advanced mapping and navigation, miniaturized tech, and precise ablation, we are addressing conditions with significant unmet needs such as heart failure, coronary artery disease, stroke, and atrial fibrillation. We are the global leaders in heart recovery, circulatory restoration and the treatment of heart rhythm disorders, as well as an emerging leader in neurovascular care, committed to taking on two of the leading causes of death worldwide in heart failure and stroke. About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more about our MedTech sector's global scale and deep expertise in cardiovascular, orthopaedics, surgery and vision solutions at . Follow us at @JNJMedTech and on LinkedIn. Shockwave Medical, Inc. is part of Johnson & Johnson MedTech. Cautions Concerning Forward-Looking Statements This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding the Shockwave Javelin Peripheral IVL Catheter. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Shockwave Medical, Inc. and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: uncertainty of commercial success; challenges to patents; competition, including technological advances, new products and patents attained by competitors; manufacturing difficulties and delays; product efficacy or safety concerns resulting in product recalls or regulatory action; changes to applicable laws and regulations, including global health care reforms; changes in behavior and spending patterns of purchasers of health care products and services; and trends toward healthcare cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at , or on request from Johnson & Johnson. Neither Shockwave Medical, Inc. nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments. † Dr. Corl is a paid consultant for Shockwave Medical. He has not been compensated in connection with this press release. 1 2 3 Media Contact : Rachael Jarnagin [email protected] Investor Contact: Tracy Menkowski [email protected] SOURCE Johnson & Johnson MedTech WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Vesalio Introduces pVasc™ U.S. clinical study initiative to capture real-world data and optimize results for patients suffering from peripheral vascular disease PLANO, Texas, Oct. 25, 2024 /PRNewswire/ -- Vesalio, a global thrombectomy company dedicated to advancing patient care across all vascular diseases, announces the initiation of a prospective, single-arm, multi-center study supporting the recently launched pVasc™ Thrombectomy System for non-surgically removing peripheral occlusions. This multidisciplinary clinical research initiative aims to collect real-world insights on the pVasc System in treating patients suffering from peripheral arterial occlusions (PAD) that may lead to acute limb ischemia (ALI). Continue Reading pVasc Thrombectomy System Current thrombectomy tools encounter multiple challenges, including difficulty accessing smaller arteries, prolonged time to flow restoration, and the risk of distal embolization. The pVasc system, featuring next generation Drop Zone™ technology and a unique, low-profile design, is specifically engineered to address these limitations. The pVasc study will generate vital real-world evidence to support the optimization of revascularization techniques and outcomes for patients with PAD-related conditions such as ALI. Vesalio will be attending the TCT Conference (Washington, D.C., Oct. 27-30), VIVA (Las Vegas, Nov. 3-6), and VEITH Symposium (New York, Nov. 19-23) in the coming weeks. These events provide Vesalio the opportunity to connect with leading vascular experts to discuss the pVasc™ Thrombectomy System for the treatment of PAD as well as the corresponding data collection plan. "The recent launch of pVasc in the U.S. represents a major milestone in our commitment to innovating to improve patient outcomes in vascular occlusion," said Steve Rybka, CEO of Vesalio. "We expect the post-market collection of real-world data to further validate the capabilities of our technology in addressing the challenges of peripheral vascular disease. We continue to support physicians with both technology and data to achieve the best possible outcomes for their patients." About Vesalio Founded in 2017, Vesalio is a privately held medical device company focused on advancing patient care in vascular diseases by providing physicians with superior technology for improving clinical outcomes. Vesalio's proprietary NeVa™, enVast™, and pVasc™ platforms are designed to effectively remove all types of clots, leading to the revitalization of compromised ischemic tissue in the brain, heart, and peripheral anatomy. Vesalio's products have treated more than 12,000 patients in over 50 countries. For more information, visit . SOURCE Vesalio WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED