<p>Corvention 新获得 FDA 批准的 KardiaPSI™气囊导管提供高达 24 atm 的超高压解决方案，帮助结构性心脏介入医生有效、强力且快速地扩张钙化狭窄的主动脉瓣，其工作长度为 2.5 厘米。</p>
<p>, /PRNewswire/ -- 结构性心脏医疗设备公司 Corvention 今天宣布，其 <strong>KardiaPSI™气囊导管</strong> 已获得美国食品药品监督管理局（FDA）的 510(k) 批准。该设备适用于气囊主动脉瓣成形术（BAV），为介入医生提供一种超高压解决方案，旨在精确扩张狭窄的主动脉瓣。</p>
<p>继续阅读</p>
<p><img src="https://imageproxy.pbkrs.com/https://www.prnewswire.com/news-releases/null?x-oss-process=image/auto-orient,1/interlace,1/resize,w_1440,h_1440/quality,q_95/format,jpg" alt="" original-src="https://imageproxy.pbkrs.com/https://www.prnewswire.com/news-releases/null"/></p>
<p>介绍 KardiaPSI 气囊导管</p>
<p>KardiaPSI™平台旨在解决钙化瓣膜解剖结构的机械挑战。通过提供高压扩张、可控扩展和短小的占地面积，该系统在瓣膜成形术中提供了新的可预测性和准确性。</p>
<p><strong>高管观点</strong></p>
<p>&#34;KardiaPSI™气囊导管的开发旨在解决瓣膜成形术中的一个根本问题：在钙化解剖结构中无法始终如一且可靠地提供足够的力量和精确控制。&#34; Corvention 的首席执行官兼联合创始人 <strong>Michael Franklin</strong> 表示。&#34;凭借超高压能力和短小稳定的工作特性，KardiaPSI 旨在提供传统气囊无法实现的可预测性。FDA 的批准使我们能够将这一能力引入临床实践，为医生提供可靠的高性能工具，拓展复杂病例的可能性。在进入商业化阶段时，我们致力于进行有序、高接触的推广，并对我们服务的临床领域负责任，专注于支持改善和持久的患者结果。&#34;</p>
<p><strong>Corvention 顾问委员会主席 Dr. Scott Lim</strong> 补充道：&#34;我们需要一种短小、强力且可控的 BAV 选项，而 KardiaPSI™技术旨在迎接这一挑战。这一批准使我们能够开始向将该技术作为结构性心脏介入工具包的标准组件过渡。&#34;</p>
<p><strong>商业准备更新</strong></p>
<p>在这一监管里程碑之后，Corvention 正在启动受控的分阶段市场引入。为了确保最高标准的临床支持和医生培训，公司将专注于建立成功全国发布所需的商业基础设施和战略支持网络。若希望在这一早期推广阶段优先考虑您的中心，请通过 https://corvention.com/contact-us/与我们联系。</p>
<p><strong>关于 KardiaPSI™技术：</strong></p>
<p>KardiaPSI™气囊导管采用纤维增强材料设计，旨在提供：</p>
<ul>
<li><strong>超高压性能：</strong> 设计用于在极端压力下保持轮廓和完整性，以破坏重度钙化（24 atm RBP）。</li>
<li><strong>精确尺寸：</strong> 设计允许医生逐毫米&#34;调节&#34;治疗，优化解剖适配，同时最小化与不必要结构的相互作用，工作长度为 2.5 厘米。</li>
<li><strong>程序效率：</strong> 使用单个注射器/充气装置快速充气/放气。</li>
</ul>
<p>Corvention 总部位于亚利桑那州弗拉格斯塔夫，是一家致力于开发现代导管实验室中结构性心脏介入专用工具的医疗设备公司。公司成立于 2021 年，专注于开发提高心血管介入临床安全性、有效性和可预测性的精密工具。</p>
<p>欲了解更多信息，请访问我们的网站 https://www.corvention.com</p>
<p>媒体联系人：</p>
<p>Alex Froimovich</p>
<p>[email protected]</p>
<p>来源：Corvention</p>
<p><img src="https://imageproxy.pbkrs.com/https://rt.prnewswire.com/rt.gif/query-RGF0ZUlkPTIwMjYwNTExJk5ld3NJdGVtSWQ9TEE1NTI5MyZUcmFuc21pc3Npb25fSWQ9MjAyNjA1MTEwNzAyUFJfTkVXU19VU1BSX19fX19MQTU1Mjkz?x-oss-process=image/auto-orient,1/interlace,1/resize,w_1440,h_1440/quality,q_95/format,jpg" alt="" original-src="https://imageproxy.pbkrs.com/https://rt.prnewswire.com/rt.gif/query-RGF0ZUlkPTIwMjYwNTExJk5ld3NJdGVtSWQ9TEE1NTI5MyZUcmFuc21pc3Npb25fSWQ9MjAyNjA1MTEwNzAyUFJfTkVXU19VU1BSX19fX19MQTU1Mjkz"/></p>

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<p>Corvention 已获得 FDA 510(k) 认证，批准其 KardiaPSI™ 球囊导管，该导管专为球囊主动脉瓣成形术（BAV）设计。该设备提供超高压解决方案，以精确扩张钙化的主动脉瓣，增强手术的可预测性和准确性。公司计划进行受控市场推广，重点支持临床和医生培训，以确保成功实施。KardiaPSI™ 技术旨在通过提供可靠的高性能工具来解决瓣膜成形术中的挑战，特别是在复杂病例中</p>

<p>Corvention's newly FDA-cleared KardiaPSI™ Balloon Catheter delivers an ultra high-pressure 24 atm solution for structural heart interventionalists, enabling controlled, powerful and fast dilation of calcified stenotic aortic valves with its 2.5 cm working length.</p>
<div class="lb-trans"><p>Corvention 新获得 FDA 批准的 KardiaPSI™气囊导管提供高达 24 atm 的超高压解决方案，帮助结构性心脏介入医生有效、强力且快速地扩张钙化狭窄的主动脉瓣，其工作长度为 2.5 厘米。</p>
</div><p>, /PRNewswire/ -- Corvention, a structural heart medical device company, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its <strong>KardiaPSI™ Balloon Catheter</strong>. The device is indicated for balloon aortic valvuloplasty (BAV), providing interventionalists with a n ultra high-pressure solution designed for the precise dilation of stenotic aortic valves.</p>
<div class="lb-trans"><p>, /PRNewswire/ -- 结构性心脏医疗设备公司 Corvention 今天宣布，其 <strong>KardiaPSI™气囊导管</strong> 已获得美国食品药品监督管理局（FDA）的 510(k) 批准。该设备适用于气囊主动脉瓣成形术（BAV），为介入医生提供一种超高压解决方案，旨在精确扩张狭窄的主动脉瓣。</p>
</div><p>Continue Reading</p>
<div class="lb-trans"><p>继续阅读</p>
</div><p><img src="https://imageproxy.pbkrs.com/https://www.prnewswire.com/news-releases/null" alt="" original-src="https://www.prnewswire.com/news-releases/null"/></p>
<p>Introducing the KardiaPSI Balloon Catheter</p>
<div class="lb-trans"><p>介绍 KardiaPSI 气囊导管</p>
</div><p>The KardiaPSI™ platform was engineered to address the mechanical challenges of calcified valve anatomy. By delivering high-pressure dilation with controlled expansion and a short footprint, the system offers a new level of predictability and accuracy during valvuloplasty procedures.</p>
<div class="lb-trans"><p>KardiaPSI™平台旨在解决钙化瓣膜解剖结构的机械挑战。通过提供高压扩张、可控扩展和短小的占地面积，该系统在瓣膜成形术中提供了新的可预测性和准确性。</p>
</div><p><strong>Executive Perspectives</strong></p>
<div class="lb-trans"><p><strong>高管观点</strong></p>
</div><p>&#34;The KardiaPSI™ Balloon Catheter was developed to solve a fundamental problem in valvuloplasty: the inability to consistently and reliably deliver sufficient force with precise control in calcified anatomy.&#34; said <strong>Michael Franklin, CEO and Co-Founder of Corvention.</strong> &#34;With ultra high-pressure capability and a short, stable working profile, KardiaPSI is designed to provide a level of predictability not achievable with conventional balloons. FDA clearance allows us to bring this capability into clinical practice, equipping physicians with reliable, high-performance tools that expand what is possible in complex cases. As we enter commercialization, we are committed to a disciplined, high-touch rollout and to being responsible stewards of the clinical spaces we serve, with a focus on supporting improved and durable patient outcomes.&#34;</p>
<div class="lb-trans"><p>&#34;KardiaPSI™气囊导管的开发旨在解决瓣膜成形术中的一个根本问题：在钙化解剖结构中无法始终如一且可靠地提供足够的力量和精确控制。&#34; Corvention 的首席执行官兼联合创始人 <strong>Michael Franklin</strong> 表示。&#34;凭借超高压能力和短小稳定的工作特性，KardiaPSI 旨在提供传统气囊无法实现的可预测性。FDA 的批准使我们能够将这一能力引入临床实践，为医生提供可靠的高性能工具，拓展复杂病例的可能性。在进入商业化阶段时，我们致力于进行有序、高接触的推广，并对我们服务的临床领域负责任，专注于支持改善和持久的患者结果。&#34;</p>
</div><p><strong>Dr. Scott Lim, Chair of Corvention's Advisory Board</strong>, added: &#34; We needed a short, powerful and controlled BAV option, and The KardiaPSI™ technology is designed to meet that challenge head-on. This clearance allows us to begin the transition toward making this technology a standard component of the structural heart interventional toolkit.&#34;</p>
<div class="lb-trans"><p><strong>Corvention 顾问委员会主席 Dr. Scott Lim</strong> 补充道：&#34;我们需要一种短小、强力且可控的 BAV 选项，而 KardiaPSI™技术旨在迎接这一挑战。这一批准使我们能够开始向将该技术作为结构性心脏介入工具包的标准组件过渡。&#34;</p>
</div><p><strong>Commercial Readiness Update</strong></p>
<div class="lb-trans"><p><strong>商业准备更新</strong></p>
</div><p>Following this regulatory milestone, Corvention is initiating a controlled, phased market introduction. To ensure the highest standard of clinical support and physician training, the company will focus its current efforts on establishing the necessary commercial infrastructure and strategic support networks required for a successful national launch. To prioritize your center during this early rollout, please reach out to us through https://corvention.com/contact-us/</p>
<div class="lb-trans"><p>在这一监管里程碑之后，Corvention 正在启动受控的分阶段市场引入。为了确保最高标准的临床支持和医生培训，公司将专注于建立成功全国发布所需的商业基础设施和战略支持网络。若希望在这一早期推广阶段优先考虑您的中心，请通过 https://corvention.com/contact-us/与我们联系。</p>
</div><p><strong>About the KardiaPSI™ Technology:</strong></p>
<div class="lb-trans"><p><strong>关于 KardiaPSI™技术：</strong></p>
</div><p>The KardiaPSI™ balloon catheter is designed with fiber-reinforced materials intended to provide:</p>
<div class="lb-trans"><p>KardiaPSI™气囊导管采用纤维增强材料设计，旨在提供：</p>
</div><ul>
<li><strong>Ultrahigh-Pressure Performance:</strong> Engineered to maintain profile and integrity under extreme pressures required to disrupt heavy calcification (24 atm RBP).</li>
<li><strong>Precision Sizing:</strong> Designed to allow physicians to &#34;dial up&#34; treatment millimeter by millimeter, optimizing anatomical fit, while minimizing interaction with unwanted structures with a 2.5 cm working length.</li>
<li><strong>Procedural efficiency:</strong> Fast inflation/deflation using a single syringe/inflation device.</li>
</ul>
<div class="lb-trans"><ul>
<li><strong>超高压性能：</strong> 设计用于在极端压力下保持轮廓和完整性，以破坏重度钙化（24 atm RBP）。</li>
<li><strong>精确尺寸：</strong> 设计允许医生逐毫米&#34;调节&#34;治疗，优化解剖适配，同时最小化与不必要结构的相互作用，工作长度为 2.5 厘米。</li>
<li><strong>程序效率：</strong> 使用单个注射器/充气装置快速充气/放气。</li>
</ul>
</div><p>Based in Flagstaff, Arizona, Corvention is a medical device company dedicated to the development of specialized tools for structural heart interventions in modern-day catheterization laboratories. Founded in 2021, the company focuses on developing precision tools that enhance clinical safety, efficacy, and predictability of cardiovascular interventions.</p>
<div class="lb-trans"><p>Corvention 总部位于亚利桑那州弗拉格斯塔夫，是一家致力于开发现代导管实验室中结构性心脏介入专用工具的医疗设备公司。公司成立于 2021 年，专注于开发提高心血管介入临床安全性、有效性和可预测性的精密工具。</p>
</div><p>For more information, visit us at https://www.corvention.com</p>
<div class="lb-trans"><p>欲了解更多信息，请访问我们的网站 https://www.corvention.com</p>
</div><p>Media Contact:</p>
<div class="lb-trans"><p>媒体联系人：</p>
</div><p>Alex Froimovich</p>
<div class="lb-trans"><p>Alex Froimovich</p>
</div><p>[email protected]</p>
<div class="lb-trans"><p>[email protected]</p>
</div><p>SOURCE Corvention</p>
<div class="lb-trans"><p>来源：Corvention</p>
</div><p><img src="https://imageproxy.pbkrs.com/https://rt.prnewswire.com/rt.gif/query-RGF0ZUlkPTIwMjYwNTExJk5ld3NJdGVtSWQ9TEE1NTI5MyZUcmFuc21pc3Npb25fSWQ9MjAyNjA1MTEwNzAyUFJfTkVXU19VU1BSX19fX19MQTU1Mjkz" alt="" original-src="https://rt.prnewswire.com/rt.gif?NewsItemId=LA55293&amp;Transmission_Id=202605110702PR_NEWS_USPR_____LA55293&amp;DateId=20260511"/></p>

Corvention 宣布 KardiaPSI™球囊导管获得 FDA 510(k) 许可