Medical Device Daily Contributing Writer

SAN ANTONIO – The annual gathering of the American Urological Association (AUA; Linthicum, Maryland), held here this week, was a milestone, the organization’s 100^th annual meeting. About 10,000 physicians from around the world attended, gathering a wealth of information for their predominantly male patients.

A wide variety of topics typically are covered at the AUA meeting and this year was no exception. One of the key issues in the urology community centers on malignant prostatic disease, known as prostate cancer.

Prostate cancer perennially captures significant attention at any AUA meeting, because it is by far the most common type of cancer found in American men, accounting for about one-third of all male cancers. According to the American Cancer Society (ACS; Atlanta), there will be about 232,000 new cases of prostate cancer in the U.S. this year, resulting in about 30,000 deaths. Prostate cancer is the second-leading cause of cancer death in men, exceeded only by lung cancer.

There are several key technologies that form the mainstay for prostate cancer therapy, including various forms of radiation such as external beam and brachytherapy (radioactive seed implants) and the “gold standard,” surgical excision of the prostate gland (radical prostatectomy, or RP).

For many years, open RP was the gold standard, but as laparoscopic technology become available it was introduced to urology in the early 1990s. Initially, laparoscopic RP (LRP) was not particularly successful, because of a restricted operating space, relatively poor visualization and a limited degree of freedom to manipulate the laparoscopic instruments.

One speaker at this week’s AUA meeting showed a slide featuring a headline from an issue of Urology Times several years ago that read “Laparoscopic Radical Prostatectomy Requires a High Degree of Skill.” As a result, LRP has failed to become a mainstream intervention for prostate cancer surgery.

The introduction of the Intuitive Surgical (Sunnyvale, California) da Vinci Surgical System – a computer-enhanced, laparoscopic surgical robot – a few years ago has had an enormous impact on the field of minimally invasive prostate cancer surgery. Although the early acceptance of this device, which costs about $1.1 million, and the associated procedure, which is called the da Vinci radical prostatectomy (DVP), was sluggish, powerful momentum has built in the past couple of years.

According to a recent Piper Jaffray (Minneapolis) report authored by Timothy Nelson, the DVP procedure now accounts for more than half of total Intuitive procedures, which he estimates at about 24,000 in 2004 and 37,000 in 2005. Interpolating from Nelson’s revenue model, it appears that DVP will generate about 22,000 to 23,000 procedures in 2005, the vast majority in the U.S.

Market watchers estimate that about 70,000 to 80,000 radical prostatectomy procedures will be performed in 2005 in the U.S., which would mean that about 25% to 30% of all RPs will be performed with the da Vinci system.

The number of RPs is likely to increase in the future, as an article in the May 12 issue of The New England Journal of Medicine, titled “Radical Prostatectomy versus Watchful Waiting in Early Prostate Cancer,” concluded that RP “reduces overall mortality and the risks of metastasis and local progression” compared to watchful waiting, a choice that many early stage prostate cancer patients opt for.

There appear to be two key drivers to DVP’s explosive growth. First, the clinical benefit appears to be as good as or better than traditional RP. A recent article in the British Journal of Urology, authored by Ash Tewari, MD, et. al from Henry Ford Health System (Detroit), concluded that this procedure “appears to be safer, less bloody and requires shorter hospitalization and catheterization.”

Perhaps more importantly, many hospitals that purchase the da Vinci experience an increase in overall patient census, which financially benefits the institutions. Speaking at the crowded Intuitive booth, Joseph Wagner, MD, of the Hartford Hospital (Hartford, Connecticut), showed statistics that his hospital’s overall prostate cancer surgery procedures rose substantially once the da Vinci system was installed.

“There is no doubt that DVP has benefited our hospital’s reputation and increased patient demand,” Wagner said.

Nevertheless, in spite of its obvious technological prowess and clinical efficacy, this device has its detractors, primarily because of its huge initial cost and the ongoing large expense of the disposables, which Piper Jaffray’s Nelson estimates at about $1,500 per case.

At an AUA-sponsored press conference on “Laparo-scopic Prostatectomy,” Jean Joseph, MD, of the University of Rochester (Rochester, New York), praised the da Vinci device as “wonderful technology, perhaps the best we’ve seen in urology.” He further commented that “it has enabled many urologists, who were not proficient at laparoscopic prostatectomy, to perform it successfully.”

However, Joseph criticized the financial dynamics of DVP, saying that it is not cost-effective. He noted that a review of 174 cases at his institution showed that the total costs of the procedure was well below reimbursement, leading to a loss of over $1,000 per case.

“This is great technology, which is clearly here to stay,” Joseph said. “However, it is a patient-driven technology, due to direct-to-consumer advertising, and my analysis shows that it is definitely not cost-justified.”

A new entrant in laparoscopic RP is Viking Systems (Westborough, Massachusetts), which displayed its Endosite 3Di digital vision system. It provides high-resolution, 3-D images through a head-mounted display (HMD), allowing the surgeon to focus on the surgical field. Its superb image quality, seen through the HMD, will eliminate the need for surgeons to divide their attention between a monitor and the surgical field and more importantly, give them confidence to quickly and safely perform a variety of laparoscopic procedures.

Michael Haggman, MD, a urologist from Uppsula University Hospital (Uppsula, Sweden), has performed several laparoscopic prostatectomies with Viking’s system and said he is “extremely pleased” with its performance. His hospital will soon be purchasing a Viking system.

“It definitely enhances standard laparoscopy,” said Hagmann at a presentation at the Viking booth. In addition, he said it “substantially reduces” the learning curve for a physician transitioning from open surgery to a laparoscopic approach.

Viking will not compete directly with Intuitive, whose system is far easier to use because of the larger degrees of freedom provided by its proprietary Endo-wrist technology. However, for hospitals that want to provide their surgeons with a less-costly system that provides high-quality 3-D image quality, the Endosite system may be appealing.

As was the case at last year’s AUA meeting, cryoablation (cryo), or deep freezing to destroy malignant tissue, showed that it is rapidly becoming an important competitor in prostate cancer therapy. A total of 16 abstracts were presented at this year’s meeting, double that of the 2004 meeting.

An estimated 8,000 to 9,000 cases of cryo will be performed in the U.S. for prostate cancer in 2005, which represents a paltry 3% to 4% share of the annual prostate cancer market opportunity. The cryoablation market is dominated by Endocare (Irvine, California), which has captured about a 70% share. The remaining market share is owned by Oncura (Plymouth Meeting, Pennsylvania), which is now a division of GE Healthcare (Waukesha, Wisconsin).

At an analysts’ meeting held during AUA, Endocare CEO Craig Davenport said that the company’s cryo procedures (which include a small amount of non-prostate procedures) have grown dramatically from just 1,546 cases in 2001 to an estimated 6,550 in 2005. This represents a 35% compound annual growth rate and, according to Vice President of Marketing Paul Lapine, “10 years of hard work is now paying off.”

Several urologists at the analysts’ gathering praised cryo as a valued therapy for prostate cancer. Dan Rukstalis, MD, of the Geisinger Medical Center (Danville, Pennsylvania), said that he believes that cryoablation represents a “paradigm shift” in prostate cancer therapy and is by far the most flexible, with several types of cryoablation approaches employed. He cited total gland (high-risk) ablation, salvage therapy (radiation failures), focal ablation (partial cancer in the gland) and renal (small tumors).

David Ellis, MD, of Urology Associates of North Texas (Arlington, Texas), began performing cryoablation in December 2000 and proudly stated that “we believe that we have the largest cryo practice in the world,” performing about 350 cases in 2004.

Recalling the early days of cryo, he said that “I was a heretic when I started” and often heard “Are you kidding?” comments from his peers. Today, he sees cryoablation as mainstream therapy for three types of patients: non-surgical candidates, high-risk patients and self-referring, “Internet-savvy patients,” who seek out cryo on their own.