<p>Corvention 新獲得 FDA 批准的 KardiaPSI™氣囊導管提供高達 24 atm 的超高壓解決方案，幫助結構性心臟介入醫生有效、強力且快速地擴張鈣化狹窄的主動脈瓣，其工作長度為 2.5 厘米。</p>
<p>, /PRNewswire/ -- 結構性心臟醫療設備公司 Corvention 今天宣佈，其 <strong>KardiaPSI™氣囊導管</strong> 已獲得美國食品藥品監督管理局（FDA）的 510(k) 批准。該設備適用於氣囊主動脈瓣成形術（BAV），為介入醫生提供一種超高壓解決方案，旨在精確擴張狹窄的主動脈瓣。</p>
<p>繼續閲讀</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>介紹 KardiaPSI 氣囊導管</p>
<p>KardiaPSI™平台旨在解決鈣化瓣膜解剖結構的機械挑戰。通過提供高壓擴張、可控擴展和短小的佔地面積，該系統在瓣膜成形術中提供了新的可預測性和準確性。</p>
<p><strong>高管觀點</strong></p>
<p>&#34;KardiaPSI™氣囊導管的開發旨在解決瓣膜成形術中的一個根本問題：在鈣化解剖結構中無法始終如一且可靠地提供足夠的力量和精確控制。&#34; Corvention 的首席執行官兼聯合創始人 <strong>Michael Franklin</strong> 表示。&#34;憑藉超高壓能力和短小穩定的工作特性，KardiaPSI 旨在提供傳統氣囊無法實現的可預測性。FDA 的批准使我們能夠將這一能力引入臨牀實踐，為醫生提供可靠的高性能工具，拓展複雜病例的可能性。在進入商業化階段時，我們致力於進行有序、高接觸的推廣，並對我們服務的臨牀領域負責任，專注於支持改善和持久的患者結果。&#34;</p>
<p><strong>Corvention 顧問委員會主席 Dr. Scott Lim</strong> 補充道：&#34;我們需要一種短小、強力且可控的 BAV 選項，而 KardiaPSI™技術旨在迎接這一挑戰。這一批准使我們能夠開始向將該技術作為結構性心臟介入工具包的標準組件過渡。&#34;</p>
<p><strong>商業準備更新</strong></p>
<p>在這一監管里程碑之後，Corvention 正在啓動受控的分階段市場引入。為了確保最高標準的臨牀支持和醫生培訓，公司將專注於建立成功全國發布所需的商業基礎設施和戰略支持網絡。若希望在這一早期推廣階段優先考慮您的中心，請通過 https://corvention.com/contact-us/與我們聯繫。</p>
<p><strong>關於 KardiaPSI™技術：</strong></p>
<p>KardiaPSI™氣囊導管採用纖維增強材料設計，旨在提供：</p>
<ul>
<li><strong>超高壓性能：</strong> 設計用於在極端壓力下保持輪廓和完整性，以破壞重度鈣化（24 atm RBP）。</li>
<li><strong>精確尺寸：</strong> 設計允許醫生逐毫米&#34;調節&#34;治療，優化解剖適配，同時最小化與不必要結構的相互作用，工作長度為 2.5 厘米。</li>
<li><strong>程序效率：</strong> 使用單個注射器/充氣裝置快速充氣/放氣。</li>
</ul>
<p>Corvention 總部位於亞利桑那州弗拉格斯塔夫，是一家致力於開發現代導管實驗室中結構性心臟介入專用工具的醫療設備公司。公司成立於 2021 年，專注於開發提高心血管介入臨牀安全性、有效性和可預測性的精密工具。</p>
<p>欲瞭解更多信息，請訪問我們的網站 https://www.corvention.com</p>
<p>媒體聯繫人：</p>
<p>Alex Froimovich</p>
<p>[email protected]</p>
<p>來源：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 已獲得 FDA 510(k) 認證，批准其 KardiaPSI™ 球囊導管，該導管專為球囊主動脈瓣成形術（BAV）設計。該設備提供超高壓解決方案，以精確擴張鈣化的主動脈瓣，增強手術的可預測性和準確性。公司計劃進行受控市場推廣，重點支持臨牀和醫生培訓，以確保成功實施。KardiaPSI™ 技術旨在通過提供可靠的高性能工具來解決瓣膜成形術中的挑戰，特別是在複雜病例中</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 新獲得 FDA 批准的 KardiaPSI™氣囊導管提供高達 24 atm 的超高壓解決方案，幫助結構性心臟介入醫生有效、強力且快速地擴張鈣化狹窄的主動脈瓣，其工作長度為 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/ -- 結構性心臟醫療設備公司 Corvention 今天宣佈，其 <strong>KardiaPSI™氣囊導管</strong> 已獲得美國食品藥品監督管理局（FDA）的 510(k) 批准。該設備適用於氣囊主動脈瓣成形術（BAV），為介入醫生提供一種超高壓解決方案，旨在精確擴張狹窄的主動脈瓣。</p>
</div><p>Continue Reading</p>
<div class="lb-trans"><p>繼續閲讀</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>介紹 KardiaPSI 氣囊導管</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™平台旨在解決鈣化瓣膜解剖結構的機械挑戰。通過提供高壓擴張、可控擴展和短小的佔地面積，該系統在瓣膜成形術中提供了新的可預測性和準確性。</p>
</div><p><strong>Executive Perspectives</strong></p>
<div class="lb-trans"><p><strong>高管觀點</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™氣囊導管的開發旨在解決瓣膜成形術中的一個根本問題：在鈣化解剖結構中無法始終如一且可靠地提供足夠的力量和精確控制。&#34; Corvention 的首席執行官兼聯合創始人 <strong>Michael Franklin</strong> 表示。&#34;憑藉超高壓能力和短小穩定的工作特性，KardiaPSI 旨在提供傳統氣囊無法實現的可預測性。FDA 的批准使我們能夠將這一能力引入臨牀實踐，為醫生提供可靠的高性能工具，拓展複雜病例的可能性。在進入商業化階段時，我們致力於進行有序、高接觸的推廣，並對我們服務的臨牀領域負責任，專注於支持改善和持久的患者結果。&#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 顧問委員會主席 Dr. Scott Lim</strong> 補充道：&#34;我們需要一種短小、強力且可控的 BAV 選項，而 KardiaPSI™技術旨在迎接這一挑戰。這一批准使我們能夠開始向將該技術作為結構性心臟介入工具包的標準組件過渡。&#34;</p>
</div><p><strong>Commercial Readiness Update</strong></p>
<div class="lb-trans"><p><strong>商業準備更新</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>在這一監管里程碑之後，Corvention 正在啓動受控的分階段市場引入。為了確保最高標準的臨牀支持和醫生培訓，公司將專注於建立成功全國發布所需的商業基礎設施和戰略支持網絡。若希望在這一早期推廣階段優先考慮您的中心，請通過 https://corvention.com/contact-us/與我們聯繫。</p>
</div><p><strong>About the KardiaPSI™ Technology:</strong></p>
<div class="lb-trans"><p><strong>關於 KardiaPSI™技術：</strong></p>
</div><p>The KardiaPSI™ balloon catheter is designed with fiber-reinforced materials intended to provide:</p>
<div class="lb-trans"><p>KardiaPSI™氣囊導管採用纖維增強材料設計，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>超高壓性能：</strong> 設計用於在極端壓力下保持輪廓和完整性，以破壞重度鈣化（24 atm RBP）。</li>
<li><strong>精確尺寸：</strong> 設計允許醫生逐毫米&#34;調節&#34;治療，優化解剖適配，同時最小化與不必要結構的相互作用，工作長度為 2.5 厘米。</li>
<li><strong>程序效率：</strong> 使用單個注射器/充氣裝置快速充氣/放氣。</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 總部位於亞利桑那州弗拉格斯塔夫，是一家致力於開發現代導管實驗室中結構性心臟介入專用工具的醫療設備公司。公司成立於 2021 年，專注於開發提高心血管介入臨牀安全性、有效性和可預測性的精密工具。</p>
</div><p>For more information, visit us at https://www.corvention.com</p>
<div class="lb-trans"><p>欲瞭解更多信息，請訪問我們的網站 https://www.corvention.com</p>
</div><p>Media Contact:</p>
<div class="lb-trans"><p>媒體聯繫人：</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>來源：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 宣佈 KardiaPSI™球囊導管獲得 FDA 510(k) 許可