Leriche Syndrome

Meticulously Designed Rapid Exchange Catheter Now Commercially Available in the United States BUELACH, Switzerland, Feb. 8, 2024 /PRNewswire/ -- BIOTRONIK is proud to introduce the Micro Rx™ catheter, a novel rapid exchange microcatheter developed to easily enhance guidewire support during percutaneous coronary interventions (PCI). This cutting-edge device, exclusively distributed by BIOTRONIK, is manufactured by IMDS (Interventional Medical Device Solutions). Micro Rx catheter marks the fourth IMDS product BIOTRONIK has brought to the U.S., creating a compelling portfolio of devices which includes NHancer Rx, TrapIT, and ReCross catheters. The Micro Rx catheter features a reinforced distal shaft with a core wire between two layers of braids for optimal push transfer and a tapered tip with the market's smallest tip leading edge1 for high penetration force. Additionally, it features a thoughtfully engineered Proximal-End-Stop that allows for seamless integration of a guide extension catheter2 to gain additional support. The Micro Rx catheter is commercially available today in the United States and in March 2024 in Canada. Dr. Ashish Pershad, MD, Director of Interventional Cardiology at Chandler Regional Medical Center and Mercy Gilbert Medical Center, one of the first users of the MicroRx catheter, shared his experience. "It provides good support and has a low profile allowing for great tip control for coronary guidewires in complex lesions. Not having to switch out your OTW catheter after you cross a difficult lesion is a huge convenience in an era where 190 cm wires are the norm in most cath labs." Acknowledging the intricacies involved in navigating through challenging vascular anatomies, such as tortuous vessels and highly stenosed lesions, the Micro Rx catheter is designed to prioritize user-friendly intervention, eliminating the need for trapping. This approach aims to mitigate the risk of vascular trauma during procedures, subsequently reducing the overall duration of patients' exposure to the catheterization lab environment and associated risks. It has the potential to enable non-chronic total occlusion (CTO) operators to successfully treat more complex anatomies3,4. "IMDS has invested its expertise and dedication into the development of the Micro Rx catheter, with a specific focus on alleviating challenges in PCI," said Ryan Walters, President at BIOTRONIK USA. "This has resulted in a state-of-the-art solution, benefiting both physicians and the patients. We are proud to bring this innovation to the U.S. market." 1 Profile compared to Finecross® MG Coronary Micro-Guide Cathether 2 End-stop is 6F Guide Extension Catheter compatible 3 Goel PK, Sahu AK, Kasturi S, et al. Guiding principles for the clinical use and selection of microcatheters in complex interventions. Front. Cardiovasc. Med. 2022;9:724608 doi: 10.3389/fcvm.2022.724608 4 Leibundgut, G. et Al. A Novel Device for Additional Guide Wire Support to Cross Tortuous Anatomy and Tight Lesions - The Micro Rx Rapid Exchange Microcatheter. Journal of Invasive Cardiology. 1-9 Micro Rx is a trademark of IMDS. Distributed by BIOTRONIK in selected countries. Finecross is a trademark or registered trademark of Terumo Group of Companies. More about the Micro Rx catheter: here About BIOTRONIK: At BIOTRONIK, patient well-being is our top priority and has been for 60 years. BIOTRONIK is a leading global medical technology company with products and services that save and improve the lives of millions suffering from heart and blood vessel diseases as well as chronic pain. Driven by a purpose to perfectly match technology with the human body, we are dedicated innovators who develop trusted cardiovascular, endovascular and neuromodulation solutions. BIOTRONIK is headquartered in Berlin, Germany, and is represented in over 100 countries. About IMDS IMDS has, for more than 15 years, focused on developing innovative devices that push the boundaries of the treatment of complex lesions in PCI. Already recognized as an expert leader in the field of CTO and bifurcation disease, IMDS is committed to making novel devices for the treatment of everyday complexity. Working with respected physician experts, our goal is to make it easier for the majority of operators to successfully treat patients who present with complex lesions every day. IMDS is headquartered in Roden, The Netherlands. SOURCE BIOTRONIK

This study aims to compare the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis primary patency to bare metal stenting to evaluate superiority in treating complex iliac occlusive disease with the goal of informing practice guidelines around which modality is best suited for patients with this condition. FLAGSTAFF, Ariz., Jan. 16, 2024 /PRNewswire/ -- W. L. Gore & Associates, Inc. (Gore) announced today that the first patients have been enrolled in the Gore VBX FORWARD Clinical Study (NCT05811364), a global prospective, multicenter, randomized controlled trial to compare the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX Stent Graft) to bare metal stenting for patients with complex iliac occlusive disease. Continue Reading GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis "Our team is pleased to be among the first to enroll patients in this important study," said Fakhir Elmasri, M.D., Interventional Radiologist, Lakeland Vascular Institute, Lakeland, Florida. "Our first patient presented with complex, bilateral iliac disease and was randomized to treatment with VBX Stent Grafts. I look forward to seeing the results of the study to inform device selection for durable outcomes in the future." "While stenting is common when treating complex iliac occlusive disease, the question around whether to use a covered or bare metal stent remains a source of debate," said Prakash Krishnan, M.D., Interventional Cardiologist, The Mount Sinai Hospital, New York City. "This trial is designed to answer the question as to whether covered stents are the superior modality among commonly used devices in contemporary practice." The VBX FORWARD Study aims to enroll an estimated 244 subjects across 40 sites in the United States, Australia, New Zealand and Europe, randomizing them 1:1 to the VBX Stent Graft group or the control group (BMS) and conduct follow-up visits through five years from the initial procedure. "Treating complex iliac occlusive disease often comes with significant challenges, including tortuous anatomy and calcified lesions with the potential for rupture," said Melissa Kirkwood, M.D., Professor and Chief of Vascular Surgery, University of Texas Southwestern Medical Center, Dallas, Texas and VBX FORWARD Study Steering Committee Member. "The outcomes of this important trial will help determine whether the VBX Stent Graft, with its unique and versatile design, plays a meaningful role in addressing these challenges." The VBX Stent Graft offers precise delivery and supports positive outcomes in complex aortoiliac applications.1 Recently published long-term follow-up of patients treated with the VBX Stent Graft for aortoiliac occlusive disease (AIOD) demonstrates the robustness and durability of the device through five years.1 "Today marks important progress in our continuing effort to raise the bar on endovascular treatment outcomes that demonstrate a positive impact on the lives of patients who suffer from this disease," said Eric Zacharias, Medical Products Division Leader, W. L. Gore & Associates. "Not only can the results from this randomized controlled trial help determine which stent choice demonstrates better patency in patients with complex iliac occlusive disease, but it also aims to provide the quality of evidence necessary to inform practice guideline recommendations." The GORE® VIABAHN® Device family of covered stent grafts, inclusive of the VBX Stent Graft and the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface*, †, offers the flexibility and conformability to safely and confidently address even the most complex cases.‡,2,3 For more information about the GORE VIABAHN Device family of covered stent grafts, visit: Additional information about the VBX FORWARD Study is available at: Gore engineers medical devices that treat a range of cardiovascular and other health conditions. With more than 55 million medical devices implanted over the course of more than 45 years, Gore builds on its legacy of improving patient outcomes through research, education and quality initiatives. Product performance, ease of use and quality of service provide sustainable cost savings for physicians, hospitals and insurers. Gore is joined in service with clinicians and through this collaboration we are improving lives. For more information, visit goremedical.com. About Gore W. L. Gore & Associates is a global materials science company dedicated to transforming industries and improving lives. Since 1958, Gore has solved complex technical challenges in demanding environments — from outer space to the world's highest peaks to the inner workings of the human body. With more than 13,000 Associates and a strong, team-oriented culture, Gore generates annual revenues of $4.8 billion. For more information, visit gore.com. For complete indications and other important safety information for Gore commercial products referenced herein, refer to the applicable Instructions for Use (IFU). * As used by Gore, Heparin Bioactive Surface refers to Gore's proprietary CBAS® Heparin Surface. † Also referred to as the GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface in some regions. ‡ The GORE VIABAHN VBX Balloon Expandable Endoprosthesis indication includes de novo or restenotic lesions in iliac arteries, including those at the aortic bifurcation. The GORE VIABAHN Endoprosthesis indication includes lesions in the iliac arteries only. See product indications. 1. Holden A, Takele E, Hill A, et al. Long-term follow-up of subjects with iliac occlusive disease treated with the Viabahn VBX Balloon-Expandable Endoprosthesis. Journal of Endovascular Therapy. In press. 2. Piazza M, Squizzato F, Dall'Antonia A, et al. Outcomes of self expanding PTFE covered stent versus bare metal stent for chronic iliac artery occlusion in matched cohorts using propensity score modelling. European Journal of Vascular & Endovascular Surgery 2017;54(2):177-185. 3. Panneton JM, Bismuth J, Gray BH, Holden A. Three-year follow-up of patients with iliac occlusive disease treated with the Viabahn Balloon-Expandable Endoprosthesis. Journal of Endovascular Therapy 2020;27(5):728-736. Products listed may not be available in all markets. GORE, Together, improving life, PROPATEN, VBX and VIABAHN are trademarks of W. L. Gore & Associates. 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IRVINE, Calif.--(BUSINESS WIRE)--Endologix Inc. a privately held, global medical device company dedicated to providing disruptive therapies for the interventional treatment of vascular disease, announced today that the first patients underwent Percutaneous Transmural Arterial Bypass (PTAB) using the DETOUR system, since FDA approval of the system was granted. This marks the official start of its U.S. targeted market release. This press release features multimedia. View the full release here: Percutaneous Transmural Arterial Bypass (PTAB) using the DETOUR System (Graphic: Business Wire) PTAB with the DETOUR System offers a disruptive, novel approach to treating complex Peripheral Arterial Disease (PAD), enabling physicians to bypass lesions in the superficial femoral artery, by using stents routed through the femoral vein 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. For the rollout, Endologix collaborated with two healthcare systems known for clinical excellence. PTAB using the DETOUR System was first performed at Cleveland Clinic’s Sydell and Arnold Miller Family Heart, Vascular & Thoracic Institute and at Salinas Valley Health Medical Center. “We are delighted to be able to introduce PTAB using the DETOUR System into clinical use,” said Matt Thompson, MD, President, and CEO of Endologix LLC. "The DETOUR System is a pivotal addition to our product portfolio, which now offers differentiated therapies for both abdominal aortic aneurysms and PAD. The successful introduction at these leading institutions underscores our commitment to continuing to innovate on behalf of patients. Broadening our therapeutic pro a key achievement as we transform Endologix into a leading interventional vascular company.” 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. These products are designed to treat a wide spectrum of vascular disease from abdominal aortic aneurysms to lower limb peripheral vascular disease. Endologix’s current commercial EVAR (Endovascular Aneurysm Repair) products include the AFX®2 Endovascular AAA (Abdominal Aortic Aneurysms) System and the ALTO® Abdominal Stent Graft System. Endologix is wholly owned by Deerfield Management, an investment management firm committed to advancing healthcare through investment, information, and philanthropy. In April 2021, Endologix completed the acquisition of PQ Bypass, Inc., a privately held medical technology company, adding the DETOUR System and TORUS Stent Graft to the Company’s product pipeline. The company has offices and manufacturing sites in Irvine, Milpitas and Santa Rosa, California. To learn more about Endologix, please visit . INDICATIONS FOR USE: The DETOUR™ System is indicated for use for percutaneous revascularization in patients with symptomatic femoropopliteal lesions from 200mm to 460mm in length with chronic total occlusions (100mm to 425mm) or diffuse stenosis >70% who may be considered suboptimal candidates for surgical or alternative endovascular treatments. The DETOUR™ System, or any of its components, is not for use in the coronary and cerebral vasculature. CONTRAINDICATIONS: The DETOUR™ System is contraindicated in patients with: A distal common femoral artery (CFA) <7 mm in diameter. Increased risk of deep vein thrombosis (DVT), such as patients with a recent history of DVT, thrombophilia, and disseminated malignancy. Untreated flow-limiting aortoiliac occlusive disease. Lack of patent single vessel tibial runoff to ankle. Known coagulopathy, bleeding diathesis, or thrombocytopenia that cannot be medically managed. Known hypersensitivities, allergies or contraindications to: Nitinol; PTFE; aspirin; heparin; antiplatelet; anticoagulant or thrombolytic therapy; or contrast media that cannot otherwise be medically managed. Refer to Instructions for Use for more information concerning Indications, Contraindications, Specific Anatomic Considerations, Warnings, Precautions, and Adverse Events. CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. NOTE: Not all product components are available in every country. Please consult with your Endologix representative to confirm product availability. ©2023 Endologix LLC. All rights reserved. Endologix® is a registered trademark of Endologix LLC in the United States, Europe, and Japan. All other trademarks are the property of their respective owners.