It's not always the device that brings in the big bucks that has the greatest impact on patients. Such is the case with the Resonance Metallic Ureteral Stent from Cook Medical (Bloomington, Indiana), which the company says has proven to relieve extrinsic uretral compression, a painful and often debilitating side effect of cancer.

"Since its launch, the Resonance stent has proven to be a successful alternative to plastic stents, offering improved drainage rates and requiring fewer invasive stent changes for the patient," said Jerry French, senior VP and global strategic business unit leader for Cook Urology. "Cook's first commitment is to improving overall quality of life for patients. We are pleased to see the impact the Resonance stent has had over the past year in improving patient care and reducing procedural costs for both patients and their healthcare facilities."

Although the product has only been out for a little over a year, the impact it has had on patients and the response from physicians "has been pretty stellar," French told Medical Device Daily.

"This product is a product that does great, great things for a select number of people," French said. "The problem in the medical community today is we oftentimes get focused on what brings you the most money, not necessarily what's best for the patient. This is not a high-volume product."

French said he believes that because Cook is a private company, it is more capable of making decisions about product launches based on the best interest of the patient.

Cook released the Resonance stent in the U.S. last year (Medical Device Daily, Aug. 1, 2007). The development of the device was motivated by the rise in gender-specific cancers, which has led to a more aggressive approach for treatment, the company said at the time the device was launched.

This in turn has led to an increased need for ureteral drainage during chemotherapy-based cancer treatments, Cook noted. The Resonance stent's design allows the patient's urinary system to drain normally while eliminating the need for a costly nephrostomy tube that can interfere with the patient's quality of life.

For the patient, that means no drainage tubes, leg bags or bedside bags, which French says can make for a "hell of an uncomfortable life."

According to Cook, the stent's compressive and radial strength can withstand up to 25 times more extrinsic compression than plastic stents and, as a result, can remain in the patient for up to 12 months.

Because the Resonance stent, priced at $1,000, costs significantly more than the typical $150 uretral stent, French admitted he was a bit concerned about how well the device would sell.

"To be honest with you I was a little surprised. [We'd] been talking about this product and trying to figure out how we could make it and then realizing what it was going to cost and wondering how the market was going to accept it," French told MDD. "I had some questions about whether anybody would pay for it and when we brought it out almost immediately we had positive response."

According to Cook, compression is primarily a result of malignant tumors that press up against the ureter, causing it to narrow. Studies show, Cook noted, that ureteral compression from malignancy managed with standard ureteral stents that needed to be changed every three to five months resulted in an estimated cost of $4,123 a patient.

Additionally, long-term cancer patients may have health insurance policies that cap reimbursement for repeated procedures. As a result, charges for repeated stent changes may go unpaid, Cook said. The company also noted that costs associated with stent change therapy over a 12-month period could be more than double the cost of a single Resonance implantation.

"Traditional plastic stents and nephrostomy tubes require patients to undergo additional procedures approximately every three to six months and often do not offer adequate drainage to improve patient comfort," said Bodo Knudsen, MD, of Ohio State University Medical Center (Columbus).

"In my experience," he added, "the Resonance stent has reduced the number of stent changes required for patients and provides increased drainage to significantly ease patient discomfort. As a result, overall quality of life may be improved for the patient and substantial time and money may be saved through fewer visits to the hospital."