11 Apr New Nephroureteral ConvertX System Unblocks and Stents in One Procedure
MedicalResearch.com Interview with:
Dr. H. Bob Smouse
Dr. H. Bob Smouse MD
Interventional Radiology, Radiology
OSF Saint Francis Medical Center
Peoria, IL
MedicalResearch.com: What is the background for this study?
Dr. Smouse: For more than twenty years I’ve seen my patients with severe blockages of the ureter undergo two separate invasive procedures to implant one ureteral stent. Even though these procedures are done with interventional techniques, they require sedation, radiation, time off work, and occasionally have some level of pain and discomfort. Being able to potentially eliminate an entire invasive procedure for these patients has been a goal of mine for years.
ConvertX Stent
MedicalResearch.com: What are the main findings?
Dr. Smouse: All devices tested showed 100% success in implantation and 100% success in converting from an internal-external nephroureteral catheter into an internal nephroureteral stent without the need for a second invasive procedure.
MedicalResearch.com: What should clinicians and patients take away from your report?
Dr. Smouse: The ConvertX System holds great promise in eliminating an entire invasive procedure in the treatment of severe ureteral blockages. The ConvertX could potentially reduce risk, pain and radiation exposure, while significantly reducing healthcare costs.
The ConvertX System Insertion
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Dr. Smouse: These pre-clinical studies presented at SIR were performed to show feasibility and preliminary safety of the ConvertX System. With these studies, all pre-submission studies and device testing have been successfully completed and we will submit applications for the ConvertX System in the near future to the FDA for 510(k) clearance as a Class II device and for CE Marking in the European Union.
We believe that the future treatment of patients with serious ureteral blockages will be done with one procedure, not two, and as such, we plan on initiating further studies in the future.
MedicalResearch.com: Is there anything else you would like to add?
Dr. Smouse: The last major innovation in treating severe ureteral blockages by Interventional Radiologists was over two decades ago. The ConvertX System is a leap forward in technology that not only promises better patient care but should positively impact healthcare savings by eliminating an in-hospital procedure.
MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.
Citation:
Abstract presented at the April 2016 Society Investigational Radiology Meeting
Performance and Conversion of the BrightWater ConvertX™ Nephroureteral Stent System
Smouse, Williams, Stalker, Heilbrunn
DOI: http://dx.doi.org/10.1016/j.jvir.2015.12.342
To test the performance and conversion of the BrightWater ConvertX™ Nephroureteral (NU) Stent System, a device that converts from an internal-external NU catheter into an internal NU stent without an invasive procedure.
Note: Content is Not intended as medical advice. Please consult your health care provider regarding your specific medical condition and questions.
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Last Updated on April 11, 2016 by Marie Benz MD FAAD