Aortic Valve Stenosis

MARLBOROUGH, Mass. and WASHINGTON, Oct. 30, 2024 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) today announced the results of the primary endpoint of the ACURATE IDE clinical trial, which evaluated the ACURATE neo2™ Aortic Valve System in the treatment of patients with severe, symptomatic aortic stenosis at low, intermediate, high and extreme risk of open-heart surgery. The data were presented as a late-breaking clinical trial at Transcatheter Cardiovascular Therapeutics® (TCT®) 2024, the annual scientific symposium of the Cardiovascular Research Foundation® (CRF®). Continue Reading ACURATE neo2™ Aortic Valve System This randomized trial evaluated the ACURATE neo2 valve, the company's second-generation transcatheter aortic valve replacement (TAVR) technology, versus a pre-defined control valve, either the commercially available SAPIEN™ valve or the Evolut™ transcatheter aortic valve system, selected at the discretion of the implanting physician. The composite rate of all-cause mortality, stroke or rehospitalization at one year was 16.16% in the ACURATE neo2 arm and 9.53% in the control arm, not meeting the prespecified criterion for non-inferiority (posterior probability for non-inferiority was 77.9%, which is lower than the non-inferiority test threshold of 97.5%). "This trial is the largest randomized comparison of TAVR platforms and was conducted over four years, including during a global pandemic that introduced complexities for enrollment," said Michael Reardon, M.D., professor of cardiothoracic surgery at Houston Methodist DeBakey Heart & Vascular Center and co-principal investigator of the ACURATE IDE trial. "These data add to the breadth of clinical knowledge of the ACURATE valve platform and provide compelling insights on the importance of procedural optimization that will be beneficial for TAVR moving forward." Also presented in the late-breaking session were data from a post-hoc analysis to identify and evaluate expanded and under-expanded ACURATE neo2 valve frames within the ACURATE IDE trial. The company performed a review of key procedural factors, including pre- and post-dilation, which helps to prepare for, enable and confirm proper valve expansion during the procedure. Following this review, an assessment of implant quality for the ACURATE neo2 valve was initiated and highlighted that approximately 20% of the valves were under-expanded. Data from the assessment also demonstrated that the rate for death, stroke or rehospitalization at one year was similar between the ACURATE neo2 expanded group and the control group. "The data presented today give clinicians a greater understanding of the impact of procedural optimization as the TAVR space continues to rapidly evolve," said Janar Sathananthan, M.D., chief medical officer, Interventional Cardiology Therapies, Boston Scientific. "We believe the findings from the ACURATE IDE post-hoc analysis and implementation of steps to mitigate valve under-expansion may improve outcomes for the ACURATE valve and have important implications on other commercially available TAVR valves, and we look forward to studying these improved techniques in future trials of the device." Boston Scientific continues to work closely with the U.S. Food and Drug Administration on the regulatory strategy for approval of the ACURATE valve platform in the U.S. More information on the ACURATE IDE trial is available here. *In Europe, the ACURATE neo2™ Aortic Valve System and the ACURATE Prime™ Aortic Valve System are CE-marked. In the USA, the ACURATE neo2 Aortic Valve System and the ACURATE Prime Aortic Valve System are investigational devices and are restricted under federal law to investigational use only. Not available for sale. **Dr. Michael Reardon is a paid consultant of Boston Scientific Corporation. He has not been compensated in connection with this press release. About Boston Scientific Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of health care. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at and connect on LinkedIn and X, formerly Twitter. Cautionary Statement Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. 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For a further list and description of these and other important risks and uncertainties that may affect our future operations, see Part I, Item 1A – Risk Factors in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, which we may update in Part II, Item 1A – Risk Factors in Quarterly Reports on Form 10-Q we have filed or will file hereafter. We disclaim any intention or obligation to publicly update or revise any forward-looking statements to reflect any change in our expectations or in events, conditions or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements, except as required by law. This cautionary statement is applicable to all forward-looking statements contained in this document. 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WASHINGTON, Oct. 28, 2024 /PRNewswire/ -- MitrAssist Lifesciences, a leader in innovative cardiovascular medical devices, today unveiled the initial clinical results of its groundbreaking new product, SIKELIA™, during the 2024 Transcatheter Cardiovascular Therapeutics (TCT) Conference held in Washington, D.C. The early findings demonstrate promising potential in improving outcomes for patients suffering from severe symptomatic aortic stenosis. SIKELIA transthoracic heart valve (THV) is designed for transcatheter aortic valve implantation (TAVI) procedure. It features a unique polymer leaflet design which allows enhanced durability and reduced thrombogenicity and calcification while lowering production costs. SIKELIA THV is also fully retrievable at 100% frame expansion allowing reposition in case of misplacement. The clinical trial results, involving 12 patients from 4 centers, with a maximum follow up of 27 months, revealed favorable safety and performance 1-year outcomes. A significant improvement in hemodynamic performance was demonstrated by reduced mean pressure gradient and increased effective orifice area. The functional status as assessed by NYHA class, 6-minute walk test and KCCQ score was improved significantly in all measures. In addition, at 1 year follow-up, normal leaflet mobility without hypoattenuated leaflet thickening (HALT) or calcification was confirmed in all patients. "The initial clinical results of SIKELIA™ mark a significant milestone in our mission to transform patient care," said Peggy Wang, CEO of MitrAssist. "We are excited about the potential SIKELIA has to improve outcomes for patients suffering from severe aortic stenosis. SIKELIA capabilities and these initial results provide a foundation for the next phases of clinical testing, and we look forward to continuing our work to bring this innovation to physicians and patients around the world." The presentation at the TCT Conference attracted the attention of top physicians, industry leaders and medical professionals eager to explore more about the product. Dr. Xiaochun Zhang from Zhongshan Hospital and the Shanghai Medical College of Fudan University presented the initial results of this first-in-human, prospective, single-arm, multicenter study, on behalf of the study investigators. In addition to Zhongshan Hospital, the participating centers included Fuwai Yunnan Hospital, Chinese Academy of Medical Sciences, Xiamen Cardiovascular Hospital Xiamen University and Zibo Central Hospital. "The initial outcomes we are seeing from SIKELIA™ could represent a real breakthrough in the TAVR field," said Prof. Junbo Ge from Zhongshan Hospital, principal investigator of the clinical trial. "The potential for improving patients' outcomes is immense, and we are eager to continue gathering data and enhancing the application of this technology. These results are just the beginning, and they pave the way for more comprehensive studies in the near future." For further information, please visit MITRASSIST LIFESCIENCES LIMITED is a leading global company for innovative cardiovascular medical devices, focusing on providing advanced diagnostic and therapeutic solutions for cardiovascular patients. The company product line covers a wide range of applications in the cardiovascular field from structural heart disease to heart failure. MitrAssist is dedicated and committed to innovation and improving patient care. Logo: SOURCE MitrAssist Lifesciences WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

近日，上海纽脉医疗科技股份有限公司（以下简称“纽脉医疗”）自主研发的Prizvalve经导管主动脉瓣膜系统（以下简称“Prizvalve”）获得中国国家药品监督管理局（NMPA）批准上市，成为中国首款自研球囊扩张式经导管主动脉瓣膜产品。 这不仅是中国心脏瓣膜领域的历史性跨越，也意味着国产替代的征途再下一城。 走进上海纽脉医疗科技股份有限公司（以下简称“纽脉医疗”）的会议室，首先映入眼帘的是一幅气势磅礴的钱塘江大潮壁画，激荡着力量与希望。 “创新造福生命，这幅画象征了我们在国产医疗器械创新路上的不断追逐与突破。”纽脉医疗创始人、董事长兼首席执行官虞奇峰说。 心尖上起舞， 国产力量悄然崛起 随着全球老龄化程度不断加深，心血管疾病（包括主动脉瓣狭窄）患病率持续上升，全球及中国的主动脉瓣膜疾病患病人数逐年增加，这一变化不仅对患者的生活质量造成了严重影响，更对医疗系统提出了严峻的挑战。 目前，心脏瓣膜病主要通过药物、外科手术（SAVR）和新兴的经导管主动脉瓣置换术（TAVR）。 不过，药物治疗仅能缓解症状，不能从根本上解决问题，与SAVR相比，TAVR无需开胸，微创伤、痛苦小、恢复快等优势，成为手术高危患者的理想选择。 2010年，中国首例TAVR手术的成功，正式宣告这项革命性的技术进入中国。 国际上，爱德华SAPIEN球扩瓣膜和美敦力Corevalve自膨瓣膜分别2011年和2013年获得FDA认证。 目前，球扩式TAVR已成为国际上心脏瓣膜疾病介入领域的主要治疗方式之一，为患者提供了更为安全、有效的治疗选择。 截至2017年，全球范围内TAVR手术已有超过1万家中心完成逾35万例，其中球扩瓣膜的使用超过三分之二。 然而，由于各方面的原因，国际领先的球扩瓣产品却并未进入中国市场用于我们的患者。 国内虽有多家企业在瓣膜领域布局并有较大突破，但由于大球囊加工工艺、球扩技术和可调弯输送系统具有较高的技术壁垒，大家都“不约而同”地选择了自膨胀瓣膜的技术路线。 在我国，国产球扩式瓣膜器械仍处于起步和探索阶段。 “  “经过大量的调研与临床，我们团队发现这不仅仅是一个技术选择的问题，更是关乎无数中国心脏病患者生命质量的重大课题。球扩瓣的精确操作和临床安全性在欧美已被广泛认可，我们要做的，就是让中国患者也能享受到这种先进的技术。”虞奇峰表示：“我们不仅仅是在做产品，更是在为患者提供生命的希望。” ” 为此，虞奇峰选择了球扩瓣这条国内未曾有人走过的道路。 “我是做技术出身的，希望能给我们中国的患者攻克这个技术难关。”虞奇峰研发球扩式瓣膜的初衷很简单。 历经八年的攻坚克难，Prizvalve经导管主动脉瓣膜系统成功问世，填补了国产球扩瓣的市场空白，开启了国内膜病介入治疗球扩瓣时代，为中国主动脉瓣患者提供了更安全、有效的治疗方案。 打破国际垄断， 坚持医工结合 对于心脏瓣膜领域的医疗器械，国际市场长期被美敦力、爱德华等外资巨头占据。尤其是在经导管主动脉瓣膜领域，爱德华的球扩产品几乎是全球医院的标配。 国产替代的呼声虽高，但要打破价格高、“卡脖子”的垄断格局绝非易事。 “尽管进口器械实力强大，但国产医疗器械有其独特的优势和潜力。”虞奇峰坚信这一点，并为团队制定了明确的发展目标。 2021年，我国仅有大约0.8%符合条件的患者接受了经导管主动脉瓣置换术治疗，而全球渗透率也仅有5%，未来还有巨大发展空间。 虞奇峰回忆起研发初期时的艰难：“那时候几乎所有的市场都被国外产品占据，我们必须从零开始。”虞奇峰知道，这是一次很艰难的技术革新，但只要踏踏实实地解决问题，就一定能在市场上立足。 “我们的创新，不是盲目地追求技术上的突破，而是深刻洞察患者需求。医疗器械创新的价值，是可落地运用于实际。”因此，虞奇峰与中国结构性心脏病领域的顶级医院和PI、KOL建立长期合作关系，深入理解临床需求，与心血管疾病领域的专家们一起致力于器械的优化及创新。 “  “医生永远是了解病人需求最深的人，”虞奇峰说，“他们给了我们技术创新的方向，而我们的工程师则通过技术手段将这些需求转化为现实。” ” 在Prizvalve瓣膜系统的创新研发历程中，心内科的医生与纽脉医疗的工程师通过医学需求的精准反馈与工程技术的不断迭代，不断打磨精进产品。 在此期间，纽脉医疗与心内科医生们共同开发了数十项创新技术，特别是在经导管手术设备方面，取得了众多突破。 通过医学科学与工程技术的深度融合，纽脉医疗不仅提高了产品的临床效果，还为更多的患者提供了安全、有效的治疗选择。 “医工结合就像是两条河流的汇合，”虞奇峰打了个比喻，“医生了解病人的需求，而工程师将这些需求转化为可行的产品，这就是医工结合的核心。医学的精确与工程的创新相互作用，形成了一股强大的力量，可以克服医疗领域中许多看似无法逾越的障碍。” 这种合作模式不仅提升了企业的自主创新能力，还推动了国产医疗器械的快速发展。 目前，纽脉医疗已有460余项专利申请，其中220余项是发明专利。同时，纽脉医疗是同业中进入“绿色通道”产品数量最多、类别最广的结构性心脏病企业之一。 差异化竞争， 重视因人适材 Prizvalve产品包括多个关键部件，如输送器、瓣膜载入器和球囊扩张导管，其设计旨在提高手术的精准度和安全性，减少并发症，提高手术效果。 “  “从研发之初，我们就着重考虑了本土市场需求，优化了输送系统和支架设计，确保它更适合中国患者的生理特征，尤其是血管较小、钙化较严重的患者群体。”虞奇峰告诉记者。 ” 历经八年研发，Prizvalve终于有了和进口品牌“掰手腕”的机会。 Prizvalve瓣膜系统适用于经心脏团队结合评估为钙化的、重度退行性自体主动脉瓣狭窄，不适合接受常规外科手术置换瓣膜的患者。 输送系统优异的调弯性能可以有效避免血管并发症，并调节瓣膜的同轴性。 显影点设计及内外管结合设计可以辅助医生实现术中精准定位。 此外，该产品通过减少手术时间和创伤，更好地适应了高龄和高风险患者的需求。 最新临床试验数据也证明了这一点，Prizvalve瓣膜系统可延长和改善患者24个月的生存情况，在临床试验中展示可靠的安全性和有效性。 伴随更多临床试验数据的积累和产品的迭代优化，“我们相信，国产球扩瓣不仅会进一步提升国内主动脉瓣市场的技术水平，还将推动整个市场的良性竞争和创新。”虞奇峰说。 跨界合作， 打造中国版Biodesign 瓣膜系统植入人体后是有使用周期的。二三十年后，患者可能还有临床需求。 “  “我们必须有前瞻性的布局、储备一些新的前沿技术，所以我们和医院布局的新型联合体，会对未来技术做一些布局和安排。”虞奇峰坦言，一次创新成功是偶然，一直创新才是企业长期发展的源动力。 ” 基于丰富的新产品研发与产业化经验，他牵头成立了“纽脉奇点创新中心”，整合多所国内外研究机构、大学及医院的强项及资源，以强化行业、学界、科学家及临床医师之间的合作伙伴关系。 目前，该中心已与四川大学、华西医院、北京航空航天大学、浙江大学等知名高校及科研院所、医院联合建立多个“技术创新联合实验室”，专注于在结构性心脏病治疗领域开展跨领域、跨学科、跨专业的应用基础研究，攻克各领域的“卡脖子”难题。 纽脉奇点创新中心以先进医疗健康技术创新为重点方向的产业创新创业平台，实时追踪行业前沿创新趋势，在多个新兴的高端医疗器械领域孕育新项目，助推创新成果的孵化与落地。 以其孵化的上海焕擎医疗科技有限公司（以下简称：“焕擎医疗”）为例，2023年1月，焕擎医疗在全国颠覆性技术创新大赛领域赛中凭借“微型介入式人工心脏技术研究及样机研制”项目获得领域赛优胜项目奖，在前沿创新的道路上初露峥嵘。 联合实验室打造了涵盖医用金属材料、医用高分子材料、生物组织处理、大球囊技术的完整专有技术创新平台。 这几大技术平台相互依存、相辅相成，几乎可用于纽脉医疗布局的所有产品，也为Prizvalve系统的研发与优化奠定了坚实基础。 纽脉医疗在产学研方面的跨界合作不仅仅停留在技术开发层面，还涵盖了人才培养与产业化布局。依托纽脉奇点创新中心，纽脉医疗开设了纽脉奇点创新系列学术沙龙，聚焦全球领先的学界前沿技术在生物医学工程及医疗器械领域的创新应用，共探医疗器械发展新领域和新方向，为创新成果的落地转化提供原动力。 虞奇峰正积极探索与构建产教融合合作新模式，他认为“企业应当承担起培养创新型人才的责任，尤其是培养具有工匠精神的青年人才。” 此外，纽脉医疗还得到了政府多项政策的支持，例如上海市“科技创新行动计划”生物医药领域科技支撑项目和中小企业创新资金的助力。这些支持不仅推动了产品的技术发展，也加速了创新成果的产业化进程。 “我们需要耐心资本的支持，只有通过长期的投入和跨界合作，才能推动更广泛的创新。”产品获批后，纽脉医疗正快速推进商业化布局。虞奇峰表示：“我们将尽快开拓挂网进院和商务渠道，提前布局规划，利用辅件产品作为渠道铺垫，为将来的新产品寻找相互信任并且具有实力的渠道伙伴。” 谈及国际化发展规划， 虞奇峰说： “未来，我们期望借助 创新产品的研发及积极注册， 后发先至， 逐步开始布局海外市场， 带领真正属于中国的 国产‘智’造走出国门， 以优质的产品回馈患者， 造福全球患者。” 完整报道详见本期 《上海市生物医药简讯》 来源 | 上海科技