CA-REFLOW-MEDICAL,-INC.
16.1.2024 09:01:35 CET | Business Wire | Press release
Reflow Medical, Inc., a developer of innovative medical devices focused on cardiovascular disease, announces it has received CE (Conformité Européenne) Mark certification in the European Union for the Bare Temporary Spur Stent System. The device is intended to treat de novo or restenotic lesions in the infrapopliteal arteries with a commercially available drug-coated balloon (DCB) to enhance drug absorption.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240116803175/en/
The Bare Temporary Spur Stent System is a unique clinical solution known as Retrievable Stent Therapy, or RST. It is intended to provide stent-like results while leaving no metal behind. (Graphic: Business Wire)
“The device performance and clinical study data for patients suffering from CLTI has been quite impressive,” said Professor Thomas Zeller, MD, who is Chief of the Department of Angiology at University Heart Center Freiburg in Bad Krozingen, Germany. CLTI, or chronic limb-threatening ischemia, increases the risk of mortality, amputation, and impaired quality of life. Prof. Zeller was a principal investigator in the DEEPER OUS clinical trial (NCT03807531).
The Bare Temporary Spur Stent System, followed by drug-coated balloon treatment, reduces clinically driven target lesion revascularization (CD-TLR), improves wound healing, reduces recoil, and improves vessel patency through one year, compared to historical treatment outcomes with plain balloon angioplasty or a DCB alone.
Marianne Brodmann, MD, is a Professor and Vascular Specialist with the Division of Angiology, Medical University Graz in Graz, Austria, and the Principal Investigator for the DEEPER LIMUS clinical trial (NCT04162418) to evaluate the Bare Temporary Spur Stent System. “We have found that the Spur allows us to treat patients with (BTK) disease using stent therapy, without the long-term risk of a stent implant,” she said.
The Bare Temporary Spur Stent System is a unique clinical solution intended to provide stent-like results while leaving no metal behind. Known as Retrievable Stent Therapy, or RST, the self-expanding stent is designed with radial spikes for creating channels in the vessel wall to enhance drug absorption and reduce recoil. The stent is then recaptured, removed, and treated with a commercially available drug-coated balloon.
“Earning the CE Mark is a huge milestone for the company. It enables us to offer a clinically validated solution to an unmet need in a major disease area,” said Isa Rizk, Reflow Medical’s Co-Founder and CEO. “Our next goal is to expand our organization to commercialize this breakthrough technology and serve the needs of physicians and their patients in countries accepting this certification.”
The Reflow Medical Bare Temporary Spur Stent System was granted certification as a Class IIa medical device under the European Union Medical Device Regulation (2017/745). The EU MDR is a rigorous process that requires manufacturers to provide substantial evidence of their device’s performance and safety.
About Reflow Medical, Inc.
Reflow Medical, Inc., established in 2011, is a private company focused on empowering physicians through the design and development of innovative and effective technologies for treating cardiovascular disease.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240116803175/en/
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Cognite Positioned as a Front Runner in LNS Research Solution Selection Matrix for Industrial AI Platforms23.4.2026 20:00:00 CEST | Press release
Cognite, the global leader in Industrial AI, has been named a Front Runner in the LNS Research Solution Selection Matrix for Industrial AI Platforms (SSM). The LNS Research SSM evaluates vendors using a rigorous methodology that leverages its “3P” framework—Product, Potential, and Presence—to assess both current capabilities and future readiness. Within the report, Cognite is recognized in three key areas: depth in user-centric industrial AI applications, its knowledge graph-based data model, and its strong partner ecosystem. Together, all three give Cognite the ability to unify and contextualize complex industrial data, enabling organizations to operationalize AI at scale. “Cognite brings a sophisticated data model built for industrial complexities, along with advanced analytics and AI-driven insights, which is crucial for industrial organizations to achieve meaningful productivity gains and enterprise-wide ROI,” said Vivek Murugesan, Research Analyst at LNS Research. “These capabilit
Venture Global Announces Closing of $750,000,000 Senior Secured Notes by Venture Global Calcasieu Pass, LLC23.4.2026 19:47:00 CEST | Press release
Venture Global, Inc. (“Venture Global”, NYSE: VG) announced today that its subsidiary, Venture Global Calcasieu Pass, LLC (“VGCP”) has closed an offering of $750,000,000 aggregate principal amount of 6.000% senior secured notes due 2036 (the “Notes”). The Notes will mature on May 1, 2036. VGCP used the net proceeds from the offering, together with cash on hand and proceeds received from certain hedge terminations, for the prepayment, in full, of VGCP’s outstanding term loans, and to pay fees and expenses in connection with the offering. The Notes are guaranteed by TransCameron Pipeline, LLC (VGCP’s affiliate). The Notes are secured on a pari passu basis by a first-priority security interest in the assets that secure VGCP’s existing senior secured first lien credit facilities and VGCP’s existing senior secured notes. The Notes were not registered under the Securities Act of 1933, as amended (the “Securities Act”) or the securities laws of any state or other jurisdictions, and the Notes
Does Muscle Composition Identify High-Risk Individuals in Chronic Kidney Disease? New AMRA Medical Study Says Yes, Reveals Strong Link to Mortality23.4.2026 17:10:00 CEST | Press release
AMRA Medical researchers recently set out to answer the question: what is the relationship between adverse muscle composition (AMC) and mortality in kidney disease? Recent findings demonstrate that AMC, characterized by low muscle volume z-score and high muscle fat infiltration, is an independent and strong predictor of all-cause mortality in individuals with chronic kidney disease (CKD). The findings, published in Clinical Journal of the American Society of Nephrology, were based on data from the UK Biobank imaging study and further reinforce the clinical relevance of MRI-derived muscle biomarkers in identifying high-risk populations across chronic diseases. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260423198497/en/ AMRA's MRI-based muscle biomarkers in clinical trials Researchers from AMRA, alongside our collaborators at Linköping University (LiU), analyzed 894 participants with CKD using AMRA’s MRI-based body composi
Diligent Unveils AI Board Member and Agentic GRC Workforce at Elevate 202623.4.2026 15:00:00 CEST | Press release
Diligent’s agentic AI strengthens board oversight and transforms how GRC teams work — reducing manual effort and outside-advisor dependency, tightening control over sensitive workflows and enabling leaders to make faster, more defensible decisions Diligent, the AI leader in governance, risk and compliance (GRC) SaaS solutions, today unveiled a new generation of autonomous AI agents, including AI Board Member — a secure AI assistant for directors — and a coordinated network of agents embedded across the Diligent One Platform. Accessible through a single command center, agents automate multi-step workflows across governance, risk, compliance and third-party management, giving organizations the impact of a “GRC manager” without adding headcount. “AI supercharges teams that embrace it, and boards are no exception,” said Brian Stafford, President and CEO of Diligent. “With AI Board Member and a network of autonomous agents woven through the Diligent One Platform, we’re giving the C-suite an
Safe Software Bolsters Leadership Team with CFO and CPO Appointments to Drive Next Phase of Growth23.4.2026 15:00:00 CEST | Press release
CFO and CPO executive hires to enhance operational and financial performance on the company’s path to $250M by 2028 Safe Software (Safe), creator of FME, the only All-Data, Any-AI enterprise integration platform, today welcomes two executives to its leadership team as it moves into the next phase of growth. Judd Lee has been appointed as the company’s Chief Financial Officer (CFO), and Vanessa Ribreau has been appointed as Chief People Officer (CPO). Having recently crossed $100M in revenue, the expanded leadership team will further enable the company to scale as it accelerates toward its goal of reaching $250M in revenue by 2028. Judd Lee is a seasoned CFO with over 15 years of experience partnering closely with CEOs to align financial strategy and accelerate sustainable growth. He is known for his strong commitment to mentorship and for building high-performing global teams rooted in trust, morale and a shared sense of purpose. With more than two decades of financial leadership acros
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom