InnoCare Urologics announced today that it received FDA 510(k) clearance for its novel urinary safety catheter.

InnoCare Urologics 今天宣布其新型尿路安全导管已获得 FDA 510(k) 批准。

The Miami-based company says it marks the first-ever FDA clearance under new code for urinary catheters with safety features.

这家总部位于迈阿密的公司表示，它标志着FDA首次根据具有安全功能的导尿管新规范获得批准。

InnoCare designed its Egress safety catheter to eliminate the injuries that occur when traditional indwelling catheters are pulled out while the catheter balloon is still inflated. The company’s proprietary technology enables the catheter balloon to automatically deflate before a pullout occurs. This helps to avoid extensive patient harm..

InnoCare设计了出口安全导管，以消除传统留置导管在导管气囊充气时拔出时发生的伤害。该公司的专有技术使导管气囊能够在拔出之前自动放气。这有助于避免对患者造成广泛伤害。。

According to a news release, clinicians can seamlessly integrate Egress into clinical practice without additional supplies or preparation. Dr. Bruce Gardner, a radiologist at Sanford Health, said a pulled-out catheter can typically lead to significant bleeding, extended catheterization time and reparation surgery.

根据一份新闻稿，临床医生可以无缝地将出口融入临床实践，而无需额外的供应或准备。桑福德健康中心的放射科医生布鲁斯·加德纳博士说，拔出的导管通常会导致大出血、导管插入时间延长和修复手术。

Gardner called Egress a “safer alternative,” especially for patients in the ICU and those with delirium or dementia..

加德纳称外出是“更安全的选择”，特别是对于ICU患者和谵妄或痴呆患者。。

“We saw a clear need to innovate a catheter design that has seen minimal advancement since its introduction over 80 years ago,” said Bryan Pinchuk, CEO and founder of InnoCare Urologics. “The creation of this new classification code validates the need to provide a safer alternative to traditional Foley catheters.

InnoCare Urologics首席执行官兼创始人布莱恩·平丘克（BryanPinchuk）表示：“我们清楚地看到了创新导管设计的必要性，自80多年前推出以来，这种导管的进步微乎其微。”。“这种新分类代码的创建验证了需要提供一种比传统Foley导管更安全的替代品。

We are excited to bring a technology to market for millions of high-risk patients, and this milestone is a critical step in achieving that goal.”.

我们很高兴为数百万高危患者推出一项技术，这一里程碑是实现这一目标的关键一步。”。