Cook Medical (Bloomington, Indiana) reported that it has developed a new device to simplify percutaneous nephrolithotomy (PCNL) procedures, during which physicians break up and remove large kidney stones, or can use it in the bladder to break up large bladder stones.
The company said that its LithAssist has already received the nod from the FDA and that last week was the formal launch of the device.
We do have an FDA clearance for the device that we received earlier this year and we have a CE mark as well, Rebecca Walendzak, director of global product management urology for Cook, told Medical Device Daily. We ll continue to work on registrations globally that align with our current markets that we sell products in. We’re just making this available in the North American market and we ll continue to roll out to additional markets throughout the month.
LithAssist has the potential to impact the nearly 67,000 PCNL procedures are performed each year in the U.S., and the 466,000 that are performed globally.
This product addresses a significant need, Jean-Marc Creissel, global leader of Cook Medical s Urology division toldMDD. It s the first and only device of its kind that couples laser fiber access with manual suction control. Up to now the suction control was managed by a nurse. With this technology the physician would control everything, the positioning of the laser fiber as well as the suction.
He added, We could compare that to someone being in a car and one person would have the wheel and one would have the pedal. With this device, you have one driver.
Prior to the availability of LithAssist, an assistant controlled suction by kinking a tube, similar to how one would stop water flow from a garden hose. LithAssist allows physicians to control suction more easily during the procedure. The ergonomic handle allows the physician to position the laser fiber and suction with one hand. Not only does this synchronize the procedure by giving the physician more control, but it also can free an assistant to help with other aspects of the procedure.
Our goal for this product is to help physicians use their lasers for PCNL procedures in a simple way, said Creissel in a release. Streamlined procedures are beneficial for the physician, the hospital and ultimately the patient. This is just one more example of our commitment to solving problems for physicians.
The company said that the LithAssist works with any holmium laser, so hospitals can use their current equipment and don t have to purchase any additional capital equipment.
Cook said that the device is receiving a positive reception from physicians.
With a procedure like this, there s constant irrigation coming in and constant suction going out and the timing of that is something the physician wants to have control over, Walendzak said. Giving the physician the ability to have control over that suction is something they re very excited about. It helps them to be able to more effectively treat the stone with the laser and control where that stone is going. They have to have irrigation to keep that visual field open but there s also a manner in which if suction is too rapid, you re going to interfere with the process. So they re very excited about the precision and control this device gives them during the surgery.
Cook would neither confirm nor completely rule out the possibility if it would seek approval for the device for additional indications.
For us right now, this device is approved for urological indications, but we have seen the adoption of products and interest from other specialties and that s something Cook would partner with physicians to continue to work on… Walendzak told MDD.