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The Vascade MVP vascular closure device. [Image from Haemonetics]Haemonetics
Vascade MVP血管闭合装置。[来自血液学的图像]血液学
(NYSE: HAE)
(纽约证券交易所:HAE)
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today announced the full market release of its Vascade MVP XL mid-bore venous closure system.
今天宣布其Vascade MVP XL中孔静脉闭合系统正式上市。
The company made Vascade MVP XL fully available to U.S. hospitals as an option to promote rapid hemostasis.
该公司将Vascade MVP XL完全提供给美国医院,作为促进快速止血的一种选择。
Haemonetics began the initial rollout for the system, which holds FDA premarket approval, in June. That limited launch reached about 80 physicians at more than 30 hospitals for a range of different procedures. The device expands the Vascade portfolio of vascular closure systems with collapsible disc technology and resorbable collagen patches..
Haemonetics于6月开始首次推出该系统,该系统已获得FDA上市前批准。这一有限的启动惠及了30多家医院的约80名医生,他们进行了一系列不同的手术。该设备通过可折叠椎间盘技术和可再吸收的胶原贴片扩展了Vascade血管闭合系统的组合。。
Vascade MVP XL features 58% more collagen and a larger disc than the Vascade MVP system. It offers a robust closure solution for procedures requiring 10-12F sheaths (up to 15F in outer diameter). Those could include cryoablation, pulsed field ablation and left atrial appendage closure (LAAC).
与Vascade MVP系统相比,Vascade MVP XL具有58%以上的胶原蛋白和更大的椎间盘。它为需要10-12F护套(外径高达15F)的程序提供了强大的封闭解决方案。这些可能包括冷冻消融,脉冲场消融和左心耳闭合(LAAC)。
The current Vascade portfolio also includes the small-bore Vascade system with standard 5-6/7F procedural sheaths and the Vascade MVP system for mid-bore closure with 6-12F ID procedural sheaths.
目前的Vascade产品组合还包括具有标准5-6/7F程序护套的小口径Vascade系统和用于具有6-12F ID程序护套的中孔闭合的Vascade MVP系统。
“We received overwhelmingly positive feedback during our limited market release and we are excited to make VASCADE MVP XL available to physicians at all U.S. hospitals as soon as possible,” said Stew Strong, president, global hospital at Haemonetics. “With our full market release underway and an ongoing clinical trial program to broaden the indications for this device to even larger access points, VASCADE MVP XL will complement our Interventional Technologies portfolio, and underscore our aspiration to be the go-to leader in vascular closure.”.
Haemonetics全球医院总裁斯图·斯特朗(Stew Strong)表示:“在有限的市场发布期间,我们收到了压倒性的积极反馈,我们很高兴能尽快将VASCADE MVP XL提供给美国所有医院的医生。”。“随着我们正在进行全面的市场发布,以及正在进行的临床试验计划,将该设备的适应症扩大到更大的接入点,VASCADE MVP XL将补充我们的介入技术组合,并强调我们希望成为血管闭合领域的领军者。”。