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The Need

Stone treatment procedures include: Extracorporeal Shock Wave Lithotripsy (ESWL) - involving shocks wave applied outside the body to disintegrate kidney stones; Intracorporeal Shock Wave Lithotripsy (ISWL) – involving shock waves applied inside the body through a ureteroscope; and Percutaneous Nephrolithotomy (PCNL) – involving the removal of kidney stones using a nephroscope passed into the kidney through a surgical incision in the patient's back. ESWL was the leading stone treatment procedure in the US in 2009 accounting for more than 850,000 procedures (71.1%), while ISWL was second-leading with more than 273,000 procedures (22.8%). PCNL is the least common procedure with around 72,000 cases in the US (6%). Due to the combination of minimal invasiveness and efficacy, ISWL share of stone treatment procedures is expected to grow to 400,000 procedures in 2016, capturing 31% of stone treatment procedures.

In ISWL procedures it is highly desirable, and in some countries (including the US) even compulsory, to reach a stone-free condition at procedure's end in order to reduce the need for a secondary stone removal operation.

While relatively large stones can be effectively captured by stone baskets, smaller fragments, sometimes as large as 2mm, are more difficult to retrieve by baskets or to trap by the currently-marketed retention devices. These fragments may migrate back to the kidney, likely causing a recurring kidney stone condition.

Additionally, the process of breaking kidney stones into smaller fragments and trapping these effectively prolongs the procedure, exposing the patient to higher risk of tissue trauma caused by increased contact between the ureteroscope and ureter, while also increasing healing time and procedure complication rate.

The XenX™ was developed to meet the need for a stone retention system that effectively traps stone fragments larger than 1mm, while immobilizing them for further disintegration and/or removal by baskets or irrigation. Its use is expected to shorten procedure time, reduce its invasiveness and address the clear demand for a cost-effective stone retention device.