#United States #FDA Approval #Brecksville #Applied Medical #Explant Express

FDA Clearance for Explant Express®

In a significant advancement for breast implant surgeries, Applied Medical Technology, Inc. (AMT) has received FDA 510(k) clearance for its innovative breast implant suction retrieval device, known as Explant Express®. This device is designed to assist plastic and reconstructive surgeons in the efficient and controlled removal of ruptured silicone breast implants, minimizing the mess often associated with traditional techniques.

What Makes Explant Express® Stand Out?

Streamlined Design for Efficiency

The Explant Express® is engineered to connect effortlessly to standard operating room suction systems, allowing for quick and effective ruptured implant explantation without necessitating additional capital equipment or specialized training for medical staff. Its intuitive layout is aimed at reducing operating time, thereby enhancing overall surgical efficiency.

Keeping the Workspace Clean

A major concern during surgeries involving ruptured breast implants is the potential for silicone gel to contaminate gloves, instruments, and the surgical field. Explant Express® addresses this issue with its innovative design that ensures swift removal of the implant while keeping the silicone contained, thus maintaining a sterile working environment for the entire procedure.

Post-Procedure Inspection Made Easy

One of the remarkable features of Explant Express® is its separable halves. This design allows for inspection of the retrieved material post-procedure, giving medical professionals the ability to perform thorough assessments of the extracted implants. This feature enhances patient safety and surgical transparency.

The Impact of FDA Clearance

Joseph Harr, Surgical Sales Manager at AMT, expressed the significance of the FDA clearance, highlighting that, "The Explant Express® device represents a pivotal advancement in tools designed to improve efficiency, cleanliness, and control during ruptured breast implant removals." This approval is expected to not only enhance surgical practices but also contribute to better patient outcomes by reducing surgery times and complications.

Ergonomic Considerations

AMT has designed the Explant Express® with ergonomics in mind. Its no-slip grip accommodates varying hand sizes, making it accessible for different healthcare professionals. This ergonomic design ensures that the user can handle the device comfortably, further adding to the device's potential in diverse surgical settings.

Future Availability

Manufactured in the United States, the Explant Express® is part of AMT's expanding portfolio of FDA-cleared surgical solutions. The company has indicated that commercial availability of the device will be announced in the coming weeks, promising to make its innovative benefits accessible to healthcare providers soon.

AMT has a long-standing reputation for enhancing the lives of patients through innovative medical devices, and the Explant Express® device is no exception. With over four decades of dedicated service in bridging the gap between healthcare technology and patient needs, AMT is set to redefine standard practices in breast surgery.

Conclusion

In conclusion, the introduction of the Explant Express® breast implant suction retrieval device marks an important step forward in minimally invasive surgical procedures. With its capacity to improve efficiency and ensure cleanliness during delicate operations, it is expected to become a vital tool for plastic surgeons. For those interested in learning more or obtaining updates about this groundbreaking device, further information can be found at Applied Medical's official site.