There is an unmet clinical need for a non-invasive approach to manipulate stones within the kidney and ureter. Significance: The prevalence of kidney stones is steadily rising and currently affects 1 in 11 Americans at a cost of $10B annually. A significant portion of this economic burden stems from a) the half a million emergency department visits for an acute obstructed stone, and b) secondary visits and procedures related to residual fragments left after surgery. Multiple studies have shown that these residual fragments often do not pass on their own and lead to symptomatic stone events in up to 50%, and secondary surgery in 20%, of the 700,000 procedures performed yearly. Technology: Stone ClearTM is a non-invasive ultrasound based tool to move stones using acoustic radiation force. The technology is integrated with an ultrasound imager to provide real-time monitoring of stone motion. There is no pain associated with the procedure and no anesthetic is required. The technology has the potential to aid in the passage of small stones and fragments in an office setting, improve stone free rates following lithotripsy procedures, and to be used in a point-of-care environment to relieve pain by moving a stone blocking the ureter. Preliminary Data: Investigational results from a feasibility trial show the technology to be safe and effective in humans achieving stone repositioning in 14 of 15 subjects, including stones up to 11 mm, and an aggregate of 30 stone fragments passed by 4 of 6 post-lithotripsy subjects. Advancements in the system design since this trial have resulted in over 100% improvement in in our ability to move a single large stone or clusters of fragments.
Specific Aims : The first three aims of this proposal focus on tasks required for FDA and CE Mark regulatory submission, as well as future commercialization.
Aim 1 brings Stone ClearTM development under Design and Quality Systems Control.
Aim 2 conducts verification and validation testing of the Stone ClearTM therapy probe and acoustic generator under the Quality Systems established in Aim 1.
Aim 3 confirms the planned regulatory path through a de novo petition submission. Finally, Aim 4 focuses on conducting a reimbursement analysis for Stone ClearTM, which is an essential component of commercial success. The outcome from this proposal will be a verified and validated Stone ClearTM device with a clear regulatory pathway, being developed under a proper Quality System and with a reimbursement strategy in place to guide future commercialization activities.
Currently one in 11 Americans will suffer from kidney stones at an annual economic burden of $10 billion. Stone ClearTM is a new way to treat kidney stones by applying ultrasound through the skin to move them. This technology can be used to facilitate stone passage by expelling fragments from the kidney or to move an obstructing stone retrograde to relieve acute pain due to urinary obstruction. The use of Stone ClearTM could translate to reduced emergency interventions and hospitalization rates, recurring symptoms, surgical procedures, and radiation exposure through continued monitoring. This proposal aims to complete key quality assurance, verification and regulatory tasks required for FDA clearance and commercialization of the device.