New Device Improves Safety in Liver and Kidney Biopsies
Key Takeaways
- Kronos Biopsy Closure device enhances safety in liver and kidney biopsies.
- The device is clinically successful in Europe and the US.
- It is now commercially available after receiving necessary clearances.
Did You Know?
Introduction to Kronos Biopsy Closure Device
Recently, Single Pass and Mermaid Medical announced the successful use of their Kronos Biopsy Closure device in the United States. This device is specifically designed for patients undergoing percutaneous liver and kidney biopsies, which are procedures where a needle is used to remove tissue samples.
The procedures took place at MemorialCare Long Beach Medical Center, with Dr. David Tahour leading the team. This device is geared towards patients who are at a high risk of bleeding, providing a safer alternative for conducting biopsies.
Significance of the Device in Biopsies
Biopsies are critical in diagnosing various conditions, including cancer, by allowing doctors to examine tissue samples. However, these procedures can pose bleeding risks, especially in high-risk patients. The Kronos Biopsy Closure device aims to mitigate these risks, offering a groundbreaking solution that enhances safety during and after the biopsy.
Dr. Tahour, the Chief of Interventional Radiology, emphasized that this device had positive outcomes. He mentioned that its existence not only provides comfort to patients but also to physicians, understanding that there is a reliable solution for managing bleeding risks.
Clinical Success in Europe and the US
The CEO of Single Pass, Bill Colone, pointed out that the device has already shown clinical success in Europe, and now, similar positive results are evident in the US. This success strengthens their value proposition that their innovation can improve the safety of needle-guided biopsy procedures, particularly for those who are at high risk.
With the clearance from both the CE Mark under EU MDR and US FDA 510(k), the device is now commercially available, making it accessible to more healthcare providers and patients.
Training and Implementation
The procedures involving the Kronos device not only served as a medical procedure but also a training opportunity. Clinical Specialists from Mermaid Medical were trained under the guidance of Dr. Tahour to ensure they are well-prepared for future applications of the device.
This collaborative effort between Single Pass and Mermaid Medical indicates a strong partnership aimed at spreading the implementation of this safety device across medical facilities.
Future Prospects
The introduction of the Kronos Biopsy Closure device opens up new opportunities for patients who previously couldn’t undergo biopsy due to high bleeding risks. This means more individuals can be accurately diagnosed and treated for their conditions.
Moreover, the device's positive reception by both European and US medical teams suggests that we will likely see broader acceptance and usage in medical practices globally.
Conclusion
In summary, the innovation brought by the Kronos Biopsy Closure device represents a significant step forward in hepatology and nephrology. It provides a safer method for conducting essential diagnostic procedures, thus offering better patient outcomes.
This advancement showcases the importance of continuous innovation in medical technology to enhance patient care and treatment success rates.
References
- Single Pass Kronos Device Detailshttps://www.singlepass.com/kronos-biopsy-closure-device
- MemorialCare Long Beach Medical Centerhttps://www.memorialcare.org/long-beach-medical-center
- FDA 510(k) Clearancehttps://www.fda.gov/medical-devices/premarket-notification-510k
- CE Mark under EU MDRhttps://ec.europa.eu/health/md_sector/smd_products/ce_marking
