Totally Implantable Artificial Lung: Studies for FDA

描述（由申请人提供）： 在NIH SBIR资助计划（5 R44 HL 53168）的大力支持下，MC 3成功开发了一种人工肺，称为BioLung（r）。BioLung（r）的设计基于我们的专利、超低压降人工肺技术。在过去10年的开发过程中，该器械已进行了广泛的实验室试验和动物试验，并将以商业形式生产，准备在2004年8月之前进入美国和欧洲的监管程序。鉴于美国广泛而昂贵的监管程序，MC 3认为，通过与医疗器械经销商签订许可协议，从FDA获得试验用器械豁免（IDE）至关重要，以鼓励BioLung（r）在美国的推广。因此，MC 3提议继续SBIR II期资助（5 R44 HL 53168 -03），以完成必要的实验室和动物研究，以及生产工艺的质量体系评价，以提交IDE申请。此外，还将进行I期临床试验的准备工作，包括中心招募、研究方案制定和医疗报销。BioLung（r）的商业潜力巨大。将眼前的市场作为移植的桥梁.长期的潜力是作为一个桥梁，以恢复或作为替代移植的终末期肺病。目前，等待肺移植的患者人数超过3，800人。在这些患者中，只有大约25%的人会在明年接受移植，这是因为缺乏可用的供体、感染并发症以及患者的身体不足以在手术中存活。BioLung（r）有可能增加肺移植受者的数量，因为它将提供一种方法来稳定等待移植的患者，并为移植后提供支持，从而允许适当使用边缘器官供体。这种类型的结果已经在左心室辅助装置在支持心脏移植患者中的应用中看到。

DESCRIPTION (provided by applicant): With significant support from the NIH SBIR grant program (5R44HL53168), MC3 has successfully developed an artificial lung, called the BioLung(r). The BioLung(r) design is based on our patented, ultra-low pressure drop artificial lung technology. This device has undergone extensive bench top and animal testing during its development over the past 10 years, and will be manufactured in a commercial form ready to enter the U.S. and European regulatory process by August of 2004. Given the extensive and expensive regulatory process in the U.S., MC3 believes that it is essential to obtain an investigational device exemption (IDE) from the FDA in order to encourage the introduction of the BioLung(r) in the U.S. by way of a license agreement with a medical device distributor. As such, MC3 is proposing a continuation of a SBIR Phase II grant (5R44HL53168-03) to complete the necessary bench-top and animal studies, and quality systems evaluation of the manufacturing process to submit an IDE application. In addition, preparations for the Phase I clinical trial will be undertaken, including recruitment of centers, study protocol development, and medical reimbursement. The commercial potential for BioLung(r) is significant. The immediate market will be as a bridge to transplant. The long-term potential is as a bridge to recovery or as an alternative to transplant for end-stage lung disease. Currently, the number of patients awaiting lung transplantation exceeds 3,800. Of these patients, only about 25% will receive a transplant in the next year due to the scarcity of available donors, infectious complications, and because the patients are not physically strong enough to survive surgery. The BioLung(r) has the potential to increase the number of lung transplant recipients because it will provide a method to stabilize patients awaiting transplantation, and provide an option of support for post transplant, thereby, allowing the appropriate use of marginal organ donors. This type of outcome has been seen in the application of left ventricular assist devices in supporting patients for heart transplantation.