A Study to Assess Safety and Effectiveness of the JenaValve Trilogy™ Transcatheter Heart Valve System Versus Surgical Valve Replacement in Patients with Aortic Regurgitation

To demonstrate non-inferiority of the Trilogy Transcatheter Heart Valve (THV) System compared with surgical aortic valve replacement (SAVR) for treatment of subjects with clinically significant native aortic regurgitation (AR)

开始日期2025-01-01

申办/合作机构

JenaValve Technology, Inc.

NCT06594705 / Not yet recruitingN/A

Transcatheter Aortic Valve Replacement Using the JenaValve TrilogyTM Heart Valve System for Clinically Significant Aortic Regurgitation in Patients with Left Ventricular Assist Devices (LVAD)

To evaluate the safety and effectiveness of the JenaValve Trilogy™ Heart Valve System for transcatheter aortic valve replacement (TAVR) in subjects with continuous flow left ventricular assist devices (cfLVAD) and clinically significant aortic regurgitation (AR) who are indicated for TAVR

开始日期2024-10-01

申办/合作机构

JenaValve Technology, Inc.

NCT05536310 / Not yet recruitingN/A

Trilogy Heart Valve System for Management of Patients With Aortic Valve Disease: Patient Registry and Post-Market Clinical Follow-up Study

To collect information about the management of symptomatic severe Aortic Stenosis (AS) and Aortic Regurgitation (AR) using transcatheter aortic valve replacement (TAVI).

开始日期2023-03-01

申办/合作机构

JenaValve Technology, Inc.

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项与 JenaValve Technology, Inc. 相关的文献（医药）

2024-10-01·JACC: Advances

Mortality Burden for Patients With Untreated Aortic Regurgitation

Article

作者: Sharma, Rahul P. ; Thourani, Vinod H. ; Généreux, Philippe ; Kwon, Michelle ; Gillam, Linda D ; Dobbles, Michael ; Amoroso, Nicholas S ; Pinto, Duane S. ; Pellikka, Patricia A ; Pellikka, Patricia A. ; Thourani, Vinod H ; Pinto, Duane S ; Sharma, Rahul P ; Rodriguez, Evelio ; Amoroso, Nicholas S. ; Gillam, Linda D.

BackgroundAortic valve replacement (AVR) is indicated in patients with severe aortic regurgitation (AR); however, certain clinical factors may identify patients with less-than-severe AR at high mortality risk if untreated.ObjectivesThe authors sought to characterize key associations with mortality across the spectrum of AR in patients not treated with AVR from a large, contemporary database.MethodsWe analyzed patients >18 years of age with documented AR assessment in a deidentified real-world data set from 27 U.S. institutions with appropriate permissions (egnite Database, egnite, Inc). Diagnosed AR severity was extracted from echocardiographic reports using a natural language processing-based algorithm. Cox multivariable analysis modeled the impact of key factors on untreated mortality according to AR severity.ResultsIn total, 81,378 patients were included for analysis. Hazard ratios for mortality were 1.26 (95% CI: 1.18-1.35) and 2.37 (95% CI: 1.96-2.87) for moderate and severe AR, respectively. Other significant associations included left ventricular (LV) ejection fraction ≤55% (1.09 [95% CI: 1.02-1.15]), LV dilation (1.34 [95% CI: 1.21-1.48]), left atrial dilation (1.09 [95% CI: 1.03-1.16]), atrial fibrillation (1.11 [1.04-1.17]), and elevated B-type natriuretic peptide/N-terminal pro-B-type natriuretic peptide (1.71 [95% CI: 1.60-1.84]). Modeled mortality risk increased with the presence of these key factors both alone and in combination.ConclusionsIn patients with untreated AR, LV remodeling, left atrial remodeling, and other markers of cardiac damage are associated with substantial mortality risk, both for severe and moderate AR. Further study is needed to determine whether AVR is warranted in patients with less-than-severe AR with at-risk factors.

2024-07-01·Catheterization and Cardiovascular Interventions

Clinical journey for patients with aortic regurgitation: A retrospective observational study from a multicenter database

Article

作者: Amoroso, Nicholas S ; Thourani, Vinod H ; Sharma, Rahul P ; Dobbles, Michael ; Pinto, Duane S ; Kwon, Michelle ; Gillam, Linda D ; Généreux, Philippe

AbstractBackgroundData using real‐world assessments of aortic regurgitation (AR) severity to identify rates of Heart Valve Team evaluation and aortic valve replacement (AVR), as well as mortality among untreated patients, are lacking. The present study assessed these trends in care and outcomes for real‐world patients with documented AR.MethodsUsing a deidentified data set (January 2018–March 2023) representing 1,002,853 patients >18 years of age from 25 US institutions participating in the egnite Database (egnite, Inc.) with appropriate permissions, patients were classified by AR severity in echocardiographic reports. Rates of evaluation by the Heart Valve Team, AVR, and all‐cause mortality without AVR were examined using Kaplan–Meier estimates and compared using the log‐rank test.ResultsWithin the data set, 845,113 patients had AR severity documented. For moderate‐to‐severe or severe AR, respectively, 2‐year rates (95% confidence interval) of evaluation by the Heart Valve Team (43.5% [41.7%–45.3%] and 65.4% [63.3%–67.4%]) and AVR (19.4% [17.6%–21.1%] and 46.5% [44.2%–48.8%]) were low. Mortality at 2 years without AVR increased with greater AR severity, up to 20.7% for severe AR (p < 0.001). In exploratory analyses, 2‐year mortality for untreated patients with left ventricular end‐systolic dimension index > 25 mm/m2 was similar for moderate (34.3% [29.2%–39.1%]) and severe (37.2% [24.9%–47.5%]) AR.ConclusionsModerate or greater AR is associated with poor clinical outcomes among untreated patients at 2 years. Rates of Heart Valve Team evaluation and AVR were low for those with moderate or greater AR, suggesting that earlier referral to the Heart Valve Team could be beneficial.

2023-10-01·Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions

A heart valve dedicated for aortic regurgitation: Review of technology and early clinical experience with the transfemoral Trilogy system.

Article

作者: Tamm, Alexander R ; Ozkor, Mick ; Huerta, Frank de la ; Kennon, Simon ; Patel, Kush P ; Baumbach, Andreas ; Mathur, Anthony

Aortic regurgitation (AR) is associated with morbidity and premature mortality. Surgical aortic valve replacement is not an option for many patients due to an adverse surgical risk profile, whilst transcatheter aortic valve implantation with most available prostheses has demonstrated suboptimal implantation success and outcomes. The JenaValve Trilogy™ system provides an attractive solution for such patients as it utilizes clips that directly attach onto the native valve leaflets to anchor. Initially designed for transapical delivery, the current transfemoral delivery system is under investigation in the United States and approved for aortic stenosis and regurgitation in Europe. We present an expert review on the technical aspects of the Trilogy system, provide a guide for implantation, discuss the available evidence for the technology and provide illustrative case examples.

项与 JenaValve Technology, Inc. 相关的新闻（医药）

2024-09-29

·echemi

Edwards Lifesciences Cuts 40 Jobs, Stock Price Plummets! Critical Care Business Worth $30.4 Billion Sold Off, Involving Major Layoffs of 4,500 Employees!

Edward Life Sciences has announced that 40 of its employees have been notified under a global layoff plan. Chief Executive Bernard Zovighian said some employees would stay on temporarily to support the transformation of the critical care business, while others would be given the opportunity to pursue new job opportunities within the company. At the same time, Edward Life Sciences has sold its critical care business to Bidi Medical for approximately RMB 30.4 billion, in a transaction involving approximately 4,500 employees, representing 20% of the company's total workforce, who will join the Bidi Medical family. Edwards Life Sciences has a long history in the fields of structural heart disease, critical care and surgical monitoring, with a number of advanced products, including the world's first successfully implanted artificial mitral valve, renowned in the field of heart valves. However, in order to focus more on the strategic development of structural heart diseases, the company has decided to divest the critical care business. Bernard Zovighian said the spin-off aims to serve more unmet patient needs through differentiated innovation, while expanding its global leadership position, achieving sustainable growth and creating more value for shareholders. It is worth noting that in Edward Life Sciences' second quarter of 2024 results, while overall sales increased year-over-year, sales growth in transcatheter aortic valve replacement (TAVR) did not meet expectations, leading the company to lower its guidance for this business. As a result, Edward Life Sciences shares fell sharply after the release of its second quarter results. Despite this, Edward Life Sciences has not slowed down its pace in the medical field. The company completed a number of key acquisitions in July, including Affluent Medical, Innovalve Bio Medical, JenaValve Technology and Endotronix, a leader in heart failure management solutions. It further consolidated its leading position in the valve business. At the same time, the company is also investing heavily in the development of differentiated repair and replacement products for mitral and tricuspid valve diseases to meet the needs of more patients.

并购

2024-07-30

·PRNewswire

Heart Valve Devices Market to Reach US$ 38.2 Billion by 2034, Driven by Rising Cardiovascular Diseases and Innovative Minimally Invasive Procedures | TMR

Increased healthcare spending and improved access to advanced medical treatments in emerging markets support the growth of the heart valve devices market. WILMINGTON, Del., July 30, 2024 /PRNewswire/ -- The heart valve devices market was projected to attain US$ 10.9 billion in 2023. It is likely to garner an 11.7% CAGR from 2024 to 2034, and by 2034, the market is expected to attain US$ 38.2 billion. There is a strong trend towards minimally invasive techniques like transcatheter aortic valve replacement (TAVR) and transcatheter mitral valve repair (TMVR), which offer reduced recovery times and lower surgical risks. The development of advanced materials, such as biocompatible polymers and tissue-engineered valves, enhances the performance and durability of heart valve devices. Download Sample of the Report: Customizable and patient-specific valve solutions are gaining traction, driven by advancements in imaging and 3D printing technologies. The use of digital health technologies, including remote monitoring and telemedicine, is becoming more prevalent, improving patient management and outcomes. Companies can capitalize on opportunities by developing innovative products, such as next-generation valve prosthetics and advanced delivery systems, to address unmet clinical needs. Greater awareness and education about heart valve diseases and treatment options among both healthcare professionals and patients are contributing to higher diagnosis rates and treatment adoption. Supportive healthcare policies and funding for cardiovascular disease management can improve access to advanced heart valve treatments and technologies. Enhanced imaging technologies, such as echocardiography and MRI, provide better diagnostics and pre-procedure planning, leading to improved outcomes and expanded use of heart valve devices. Heart Valve Devices Market: Key Players The competitive landscape of the heart valve devices market is characterized by a dynamic environment with significant involvement from both established players and emerging companies. The following companies are well known participants in the heart valve devices market: Medtronic plc Boston Scientific Corporation Abbott Edwards Lifesciences Corporation Foldax Inc. Novostia SA Meril Life Sciences Pvt. Ltd. Corcym UK Limited JenaValve Technology Inc. Micro Interventional Devices Inc. Others Key Developments In 2024, Edwards Lifesciences announced the European launch of its SAPIEN 3 Ultra RESILIA valve. This transcatheter aortic heart valve features the company's advanced RESILIA tissue technology, designed for extended durability. Additionally, the device received CE mark approval for treating patients with heart valve disease caused by native calcific aortic stenosis. In the same year, Medtronic introduced its next-generation surgical aortic tissue valve, the Avalus Ultra Bioprosthesis. This device is designed for easy implantation, provides clear visibility for future valve-in-valve procedures, and features convenient sizing. Additionally, the valve incorporates a polyetheretherketone (PEEK) base frame to ensure consistent circularity. Heart Valve Devices Market Report Scope: Key Findings of Market Report Exploring innovative technologies, such as bioengineered heart valves and regenerative medicine approaches, offers potential breakthroughs in heart valve treatment. Investing in clinical trials and research can lead to the development of new and improved heart valve devices, establishing market leadership and differentiation. Broadening the indications for heart valve devices to include conditions beyond traditional valve diseases can create new market opportunities. The development of more sophisticated diagnostic tools and techniques for early detection and accurate assessment of heart valve diseases enhances treatment planning and outcomes. Market Trends for Heart Valve Devices By type of heart valve, the aortic valve segment is expected to boost the growth of the heart valve devices market. Aortic stenosis, particularly among the aging population, is a major driver of demand for aortic valve replacements. The condition often requires intervention when symptoms become severe, leading to increased use of aortic valve devices. The development and growing adoption of minimally invasive TAVR procedures for aortic valve replacement are driving market growth. TAVR offers advantages such as shorter recovery times and reduced surgical risks compared to traditional open-heart surgery. By material, the biological valves segment is anticipated to propel the market growth. The increasing use of transcatheter aortic valve implantation (TAVI) procedures, which predominantly use biological valves, is driving growth. Biological valves are favored in TAVI due to their design and compatibility with minimally invasive techniques. Continuous improvements in biological valve materials and technology, such as the development of more durable and biocompatible biological valves, enhance their performance and longevity, driving increased adoption. Download Sample of the Report: Global Market for Heart Valve Devices: Regional Outlook North America North America is a hub for medical device innovation, with significant investments in research and development leading to the development of advanced heart valve devices and technologies. The adoption of minimally invasive procedures, such as Transcatheter Aortic Valve Replacement (TAVR), is growing due to technological advancements that improve patient outcomes and reduce recovery times. Asia Pacific The growth of local manufacturing and partnerships with international companies enable the production and distribution of advanced heart valve devices at a lower cost, improving market accessibility. Increased focus on clinical research and development in the region supports the innovation and introduction of new heart valve technologies. Heart Valve Devices Market Segmentation Type of Heart Valve Aortic Valve Less than 20 mm 20 to 23 mm 23 to 26 mm More than 26 mm Mitral Valve Less than 26 mm 26-28 mm 29-31 mm More than 31 mm Tricuspid Valve Pulmonary Valve Material Biological Valves TAVI Surgical Others Mechanical Valves Age Group Pediatric Patients Adults Geriatric Patients End User Hospitals Ambulatory Surgical Centers Others Region North America Latin America Europe Asia Pacific Middle East & Africa Buy this Premium Research Report: More Trending Report by Transparency Market Research: Brain Implants Market - The brain implants market was valued at US$ 4.2 billion in 2022. A CAGR of 8.4% is forecast for the industry from 2023 to 2031, resulting in a market value of over US$ 8.8 billion at the end of the decade. Cuffless Blood Pressure Monitoring Devices Market - Cuffless Blood Pressure Monitoring Devices Market was valued at US$ 599.2 Mn in 2023, it is expected to grow at a CAGR of 10.8% from 2024 to 2034 and reach US$ 1.9 Bn by the end of 2034 Contact and Intraocular Lenses Market - Global Industry for Contact and Intraocular Lenses was valued at US$ 11.6 Bn in 2023, it is expected to grow at a CAGR of 6.4% from 2024 to 2034 and reach US$ 22.9 Bn by the end of 2034 Electronic Health Records Market likely to surpass USD 50 Bn by 2031, expanding at a 5% CAGR About Transparency Market Research Transparency Market Research, a global market research company registered at Wilmington, Delaware, United States, provides custom research and consulting services. Our exclusive blend of quantitative forecasting and trends analysis provides forward-looking insights for thousands of decision makers. Our experienced team of Analysts, Researchers, and Consultants use proprietary data sources and various tools & techniques to gather and analyses information. Our data repository is continuously updated and revised by a team of research experts, so that it always reflects the latest trends and information. With a broad research and analysis capability, Transparency Market Research employs rigorous primary and secondary research techniques in developing distinctive data sets and research material for business reports. Contact: Transparency Market Research Inc. CORPORATE HEADQUARTER DOWNTOWN, 1000 N. West Street, Suite 1200, Wilmington, Delaware 19801 USA Tel: +1-518-618-1030 USA – Canada Toll Free: 866-552-3453 Website: Email: [email protected] Follow Us: LinkedIn | Twitter | Blog | YouTube Logo: SOURCE Transparency Market Research

2024-07-26

·美通社

沛嘉医疗合作伙伴JenaValve公司被爱德华生命科学全资收购，经导管治疗主动脉瓣反流展新篇

苏州 2024年7月26日 /美通社/ -- 2024年7月24日，沛嘉医疗（9996.HK）合作伙伴JenaValve Technology, Inc.（以下简称为JenaValve）宣布与美国医疗器械巨头爱德华生命科学（NYSE：EW，简称"爱德华"）达成协议，爱德华生命科学将全资收购JenaValve。交易完成后，沛嘉医疗将继续拥有JenaValve Trilogy THV系统大中华区的独家权利。 2024年3月28日，拥有全球首创锚定键（Locators）设计、治疗主动脉瓣反流的JenaValve Trilogy™心脏瓣膜系统关键临床试验ALIGN-AR1年临床数据于著名医学期刊《柳叶刀》发表，试验结果振奋人心。ALIGN-AR试验数据结果的发表，无疑是经导管主动脉瓣置换术治疗主动脉瓣反流的重要里程碑，将为外科高危症状性中重度或重度主动脉瓣反流患者开创全新的介入微创治疗时代。 2021年底，沛嘉医疗和JenaValve签订了Trilogy TM 心脏瓣膜系统大中华区的独占许可，并成为JenaValve的少数股东。随后，沛嘉医疗将该技术商标更名为TaurusTrio TM 经导管主动脉瓣系统，在中国开展注册临床试验，并于2024年1月成功完成全部患者入组，进入一年随访阶段。 "作为JenaValve的合作伙伴，沛嘉医疗祝贺JenaValve和爱德华生命科学团队宣布在结构性心脏领域进行变革性合作。"沛嘉医疗董事长兼首席执行官张一博士说。ALIGN-AR试验结果于《柳叶刀》重磅发布，迅速扭转了全球医生对主动脉瓣反流治疗方案的认知。此次爱德华对JenaValve的高价收购是对该产品、技术与疗法的最高认可，将极大程度地推动主动脉瓣反流介入治疗在全球的迅速发展。根据收购协议，交易完成后，沛嘉医疗将继续拥有JenaValve Trilogy THV系统在大中华地区的独家授权。行业巨头爱德华生命科学对产品的收购将会增强全球医生对于主动脉瓣反流疾病的认知，并加速JenaValve Trilogy THV系统的发展。交易交割后，公司将与爱德华生命科学携手并进，致力于为全球各自负责市场内的主动脉瓣反流患者提供最新最好的手术方案。此次收购，标志着爱德华在经导管瓣膜产品管线上的又一次突破，其在瓣膜领域近期的几大热点都有完善布局及重大进展，包括三尖瓣置换、二尖瓣疗法、全生命周期管理/长效瓣膜、主动脉瓣反流等。作为国内结构性心脏病介入治疗龙头企业，沛嘉医疗也同样前瞻性地完整布局以下热点：经血管三尖瓣置换MonarQ、经房间隔二尖瓣置换HighLife、二/三尖瓣缘对缘修复GeminiOne、长效干瓣TaurusNXT和高分子瓣及主动脉瓣反流TaurusTrio等，持续满足海内外医生和患者对经导管瓣膜治疗产品的大量临床需求。作为结构性心脏病领域的创新型企业，沛嘉医疗在多年前已开始治疗主动脉瓣反流的技术布局。如今随着循证的发布，爆发看似水到渠成，其实离不开早期公司管理层的技术理解和战略眼光。沛嘉医疗始终认为对技术的深度理解既能帮助管线的独特性与竞争力，亦能提升外部投资的成功率。其拥有能和国际巨头比肩的完整管线，也期待管线内的更多产品能更快的开花结果。 "我们期待与爱德华等国际同行建立有意义和富有成效的关系。我们也期待行业巨头的目光能投向沛嘉医疗拥有完整权益的三尖瓣置换产品MonarQ等，以及完全由本土团队自研的缘对缘修复产品GeminiOne。"张一博士表示，沛嘉医疗对于中国的研发能力有无比的信心，循序渐进，持续努力，必能成功地走到那一步。