By LARRY HAIMOVITCH
and DIANA TUCKER
BBI Contributing Editors
SAN ANTONIO The annual gathering of the American Urological Association (AUA; Linthicum, Maryland), held here in late May, was a milestone, the organization's 100th annual meeting. More than 15,000 physicians and other clinicians assembled here to exchange the latest scientific information on current issues in their field, including prostate cancer, erectile dysfunction, incontinence and men's general health issues.
A wide variety of topics typically are covered at the AUA meeting and this year was no exception. One of the key issues for the predominantly male patients served by the urology community is malignant prostatic disease. Prostate cancer captures significant attention at every 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 became 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 year'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 report authored by Timothy Nelson of Piper Jaffray (Minneapolis), 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 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 would 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," authored by a group of Scandinavian doctors representing the Scandinavian Prostate Cancer Group Study, 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 "Laparoscopic 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 more than $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 Uppsala University Hospital (Uppsala, Sweden) and one of the several doctors who contributed to the May 12 issue of The New England Journal of Medicine article, has performed several laparoscopic prostatectomies with Viking's system and said he is "extremely pleased" with its performance. His hospital is now in the process of purchasing a Viking system.
"It definitely enhances standard laparoscopy," said Hagmann during 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 now is a division of GE Healthcare (Waukesha, Wisconsin) following the April 2004 acquisition by GE of Amersham (Little Chalfont, UK).
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.
Also in the prostate cancer arena, Drs. Daniel Chan and Zhen Zhang, of Johns Hopkins Medical School (Baltimore), presented results suggesting that two protein markers, in combination with PSA levels, may be useful in predicting risk of recurrence within five years of diagnosis.
The study, which also involved scientists from Ciphergen Biosystems (Fremont, California), analyzed serum from 104 patients with prostate cancer, half of whom had a recurrence of their cancer within five years of surgery and half of whom did not after five years of follow-up.
Ciphergen's SELDI-TOF-MS based ProteinChip System and arrays were used to analyze the serum proteomic profiles. Analysis revealed that two markers, when combined with the PSA level prior to radical prostatectomy, could more accurately predict the risk of recurrence than could PSA level alone.
One of these markers is a low-abundance molecule with a known association to PSA.
Gail Page, president of Ciphergen's Diagnostics Division, said, "Although much attention has been paid to the early detection of prostate cancer, prediction of clinical course remains problematic. These results suggest a possible method to better predict recurrence of disease and thereby offer more aggressive treatment to those with a higher likelihood of recurrence."
ED another key area
Erectile dysfunction (ED) affects between 15 million and 30 million American men, and of the approximately 9 million who seek treatment, 70% to 80% take one of the three FDA-approved phosphodiesterase type 5 inhibitors (PDE5): Viagra from Pfizer (New York), Cialis from Eli Lilly & Co. (Indianapolis) or Levitra from GlaxoExact Sciences (London). Of these, about one-third do not respond, so the urologist is left with how to counsel these patients. However, the guidelines for ED treatment were last published in 1996, prior to the FDA approval of PDE5 inhibitors. Jonathan Jarow, MD, professor of urology at Johns Hopkins University (Baltimore), and Drogo Montague, MD, professor of surgery at the Cleveland Clinic and Case Western University (Cleveland), presented the new clinical guidelines for the treatment of erectile dysfunction that now include the PDE5 inhibitors, intra-urethral alprostadil and also offers guidelines for treatment of premature ejaculation and priapism, two conditions not previously addressed.
According to the new guidelines, a complete medical history should be completed first since erectile dysfunction is a symptom of an underlying disease state such as diabetes, hypertension, hyperlipidemia or smoking (see Table 1). The fact that some of the medications for these disease states may cause sexual side effects often leads to non-compliance by the patient; by adding a PDE5 into their regimen it is believed that the patient may become more compliant with their other medications, dubbing the PDE5 inhibitors "men's health pill."
The panel recommendations are listed in Table 2 in order of preference. Unless contraindicated, oral PDE5 inhibitors were recommended as a first-line of therapy for erectile dysfunction. PDE5 inhibitors are contraindicated in men who are taking nitrate medications due to the risk for potentially harmful decreases in blood pressure. No recommendation could be made as to which PDE5 inhibitor is more effective, since direct comparative data among the three pills is not available. Table 2 also features estimated market shares for erectile dysfunction products.
Erectile dysfunction is a common side effect in men who have undergone a radical prostatectomy where nerve-sparing techniques were not an option. In a "state of the art" lecture titled "Rehabilitation of erectile function after radical prostatectomy," Francesco Montorsi, MD, of the University Vita Salute San Raffaele (Milan, Italy), discussed the current standard of care in prostate cancer patients in order to preserve sexual function following surgery. Montorsi performed a meta-analysis of all published data and found that surgeon technique was the most important factor in post-prostatectomy sexual function.
Specifically, bilateral (unilateral if necessary) nerve-sparing procedure (BNSP) should always be performed, leaving behind the nerves that allow for erection upon sexual stimulation. He found that the other factors that played a role in erectile function following prostatectomy were the number of nerve-sparing procedures the surgeon had performed, the age of the patient, and whether the patient was able to achieve an erection without help prior to surgery. In most cases of post-prostatectomy erectile dysfunction, sexual health could be achieved following the guidelines above.
Sling procedures for SUI show rapid growth
Synthetic Slings for the treatment of stress urinary incontinence (SUI) continue to evolve and grow around 20% annually, drawing new entrants into this marketplace. With an estimated 12 million Americans having incontinence episodes, it is believed that the 180,000 annual sling procedures being performed are only the tip of the iceberg. The newest technique using a transobturator approach pioneered by a French Dr. Delnorme boasts less post-op urinary retention than a retropubic or supra-pubic approach along with a perceived safety benefit of being able to better avoid hitting intestines or blood vessels. American Medical Systems (AMS; Minn-etonka, Minnesota) and Mentor (Santa Barbara, California) now have many other companies joining them in offering this perceived safer, easier, cystoscopy-optional technique. Industry analysts anticipate that in the near term, the new trans-obturator techniques will usurp market share from both the suprapubic and retropubic type of sling kits. It also is estimated that as sling procedures evolve into simpler and easier methods, reimbursement will drive them toward becoming office-based procedures.
Neomedic International (Barcelona, Spain) launched its first product in the U.S. market at the AUA meeting. The Remeex System is a readjustable, tension-free system used for sling procedures utilizing a polypropylene mesh suspended by two prolene sutures that pass through a small plastic device permanently implanted under the patient's umbilicus for future adjustment in sling tension, if ever necessary, throughout the lifetime of the patient.
The device is designed for difficult-to-treat patients, patients who have failed prior surgeries, and male incontinence patients not competing with the many other sling products currently on the market for primary treatment of stress urinary incontinence. The product was developed six years ago and has been widely used in more than 4,000 patients outside the U.S., with published studies from 26 different international journals.
It allows the surgeon to use either a retrograde or supragrade procedure, then has the patient return the next morning for an adjustment using a small screwdriver that finely tunes the exact amount of suspension required for that patient, determined by having them cough while standing and adjusting until they are dry doing so. The patient can then go home and resume normal activities immediately, knowing that if any adjustments are needed again at a later date, that it could be done in a office setting using local anesthetic. Because it is positioned for patients who are very difficult to treat or have failed prior procedures, it is premium-priced at $1,950, compared to the $700 to $1,100 price tag on slings for the first-time patient.
Of the 12 million incontinent patients in the U.S., 2 million suffer from intrinsic sphincter deficiency (ISD), a condition different from urethral hypermobility, which is best suited for a sling procedure. ISD responds best to bulking of the sphincter, but currently available bulking agents each have their own drawbacks. Contigen, made by Bard (Covington, Georgia), pioneered this area and still holds the largest market share. Contigen is a collagen-based implant that bulks the sphincter and has the largest amount of studies demonstrating its efficacy, the downside being that of durability and having the patient return for future injections over the years.
Durasphere, distributed by Boston Scientific (Natick, Massachusetts) is more durable but because it is a pyrolytic carbon coated-bead suspension, some physicians claim that it is difficult to inject. The newest injectable bulking agent on the market is Tegress, also distributed by Bard. It is an ethylene vinyl alcohol copolymer in a dimethyl sulfoxide carrier that becomes a soft spongy implant upon injection into the tissue. Since market launch came at the early-May annual meeting of the American College of Obstetricians and Gynecologists (Washington), it is too soon to tell what the response will be in the hands of many different physicians.
The next bulking agent expected to be on the market will be Macroplastique, by Uroplasty (Minneapolis), which is comprised of silicone beads suspended in a hydrogel carrier. Uroplasty is anticipating FDA approval early next year. In more than 60,000 cases performed outside of the U.S., the company has seen neither absorption nor migration of the silicon beads in the eight-year data it has collected. It also has a needle-positioning device that enables doctors who prefer not to use a cystoscope to place the injection in precise locations around the sphincter this may result in broadening its appeal to gynecologists, who do not routinely use cystoscopes in their practice. About 60,000 bulking agents will be injected in 2006, leaving a huge underserved patient caseload of more than 1 million ISD patients. Of these, only 50% will seek treatment, still leaving a potential patient pool of about 500,000 underserved patients, who could be treated in an office setting using a bulking agent.
Partially due to the rapid evolution of treatments and products for stress urinary incontinence, a panel for the AUA has convened to update the guidelines for SUI. In an AUA update lecture by Saad Juma, MD, of the University of California, San Diego, School of Medicine, he said the purpose was to define the appropriate treatments for both patients seeking treatment for SUI alone and for those seeking treatment for SUI with organ prolapse. Using the Cochrane library and a meta-analysis, he and his colleagues were able to incorporate 1,008 articles that covered 21,145 patients to identify best treatment protocol for slings, bulking agents and artificial sphincters. They anticipate an October release of the new guidelines for treatment of SUI.
Bladder cancer test shines
The NMP22 BladderChek Test from Matritech (Newton, Massachusetts) was featured in a presentation on "Advances in Bladder Cancer Detection and Screening" at the meeting. Urologists Giora Katz, MD, of the department of surgery-urology service at Lake City Veterans Affairs Hospital (Lake City, Florida) and Lake Shore Urology (Manitowoc, Wisconsin), and Edward Messing, MD, of the department of urology at the University of Rochester Medical Center (Rochester, New York), reported results from a large multi-center clinical study that showed the point-of-care NMP22 BladderChek Test detects three times as many bladder cancer malignancies as cytology, a commonly used laboratory-based urine test.
"This is good news for people at risk for bladder cancer," said Katz. "Our challenge is to improve the detection of bladder cancer; and our research showed that the BladderChek Test enhances the detection of bladder cancer, especially when combined with cystoscopy. It's very common for people with bladder cancers to be diagnosed much later than we'd like. This test is easy it is performed in the doctor's office and results are available while the patient waits and it may save lives."
Messing said the test could reduce the need to do the invasive cystoscopic urethral procedure twice, once for detection and a second time in the operating room to remove tumors. "With the NMP22 BladderChek Test, we would know the cancer cells exist. Then we could schedule the cystoscope procedure under anesthesia to remove the tumors in the operating room," he said. "This certainly advances our ability to diagnose bladder cancers more easily and less expensively. Hopefully, more at risk patients will be encouraged to be evaluated."
Katz cited his clinical experience with the NMP22 BladderChek Test at the VA Hospital in Lake City, which was one of 23 sites participating in this clinical study. "A majority of the patients in the VA are at high risk for bladder cancer because they are males, over 50 years of age and have a history of smoking," he said. "We found we can use the BladderChek Test to help direct resources to patients with the highest suspicion of cancer."
The NMP22 BladderChek Test detects elevated levels of the NMP22 protein in a single urine sample. Healthy individuals generally have very small amounts of NMP22 protein in their urine, but NMP22 protein levels often are elevated in the urine of patients with bladder cancer, even at early stages of the disease.
The performance of the NMP22 BladderChek Test was compared to voided urine cytology, which must be analyzed in a clinical laboratory. The BladderChek Test was shown to be more effective than cystoscopy alone in detecting later-stage bladder cancers.
Broad array of new products
The exhibit floor of the Henry B. Gonzalez Convention Center upheld the gathering's tradition as a stage where companies developing new products or enhancements to existing products for the broad urology treatment space roll out their latest offerings.
Endocare (Irvine, California), a company focused on the development of minimally invasive technologies for tissue and tumor ablation, along with vacuum technologies for erectile dysfunction (ED), launched eight new products at the meeting. The company said the new technologies are designed to enhance the usability and flexibility of its cryoablation tools across the range of urology applications, including renal procedures and both primary and salvage prostate cancer treatments.
Five of the new products are right-angle probes designed for the special challenges of renal cryoablation. Another is a new laparoscopic ultrasound system for Cryocare CS, along with a probe capable of making smaller ice balls for salvage cryoablation. The eight new products being shown by Endocare is a prototype of a variable, detachable CryoProbe that is designed to be adjusted by the surgeon for a variety of procedures and tumor types.
Chairman and CEO Craig Davenport said, "As the field of cryoablation expands from simply a tool to treat prostate cancer to a means of treating tumors throughout the body, product versatility and specialization must also increase." He said the addition of new tools for renal procedures, better visualization and specialized sizing "are examples of how we are responding to the demands of the market and to the physicians who are extending the clinical application of our freezing technology."
The suite of five new right-angle Renal CryoProbes offers physicians the opportunity to select the right probe for the right procedure open, laparoscopic or percutaneous. The probes range in size from 1.7 mm to 3.8 mm and are designed for ergonomic "fit" as well as the ability to apply the right size freeze for the specific patient need, Endocare said.
Cleared recently by the FDA, the new laparoscopic ultrasound probe is now available as an option with the Cryocare CS System. The probe plugs directly into the system and is controlled by the Cryocare CS keyboard. The laparoscopic ultrasound probe is a four-way articulating linear array 7.0 MHz probe with color Doppler function, making visualization during "keyhole" surgical procedures more precise and easy to use, according to the company.
The new 2.4 mm SalvageCryo Probe, designed for salvage prostate procedures, is now available for use with the Cryocare CS system, Endocare said. Salvage procedures are performed when radiation treatment has failed or the cancer has recurred after time following radiation treatment. It said the new probe forms a smaller ice ball, offering the physician more precision in the salvage procedure that often entails freezing a smaller or misshapen gland.
A prototype of the Detachable Variable CryoProbe probe was unveiled for the first time at the AUA meeting. When commercially available, the variable CryoProbe will allow physicians to use a single probe type for numerous applications and patient types. It will be able to generate an ice ball of varying size and will be capable of use in open, laparoscopic or percutaneous procedures.
Davenport said, "We are especially optimistic about the advances we are offering in the area of renal cryoablation, which is one of our fastest-growing specialties. The introduction of the new right angle probes along with the recently FDA-cleared ultrasound system further leverages our Cryocare CS platform, better allowing its use in renal procedures and putting us in front of our competition, from a technology standpoint, in the kidney tumor ablation market." Cryocare CS is a fully integrated cryosurgical planning, placement and treatment system designed to simplify targeted cryoablation procedures for prostate and kidney cancers.
Endocare has initially concentrated on developing devices for the treatment of prostate cancer but says it believes its technologies have broad applications across a number of markets, including the ablation of tumors in the kidney, lung, liver and bone.
Among other exhibitors, Laserscope (San Jose, California) introduced an enhanced version of its GreenLight laser system for photoselective vaporization of the prostate (PVP). The company said the GreenLight laser system has been re-engineered and integrated with new fiber-optic delivery device enhancements to provide physicians with even better performance through maximum fiber flexibility and control. Increased system up-time, faster new site set-up time and "real-time" response to fiber manipulation are among the features of the enhanced laser and integrated fiber-optic delivery device.
Laserscope said it would begin shipping the improved version of the system and delivery device immediately to new customers and planned to make the new features available to its current installed base through an upgrade program.
The company said the AUA meeting featured the presentation of 10 studies related to the PVP procedure, including two randomized trials comparing PVP and trans-urethral resection of the prostate (TURP), the surgical "gold standard" for benign prostatic hyperplasia (BPH), or enlarged prostate. Laserscope said the randomized studies mark "a significant milestone," because they "independently affirm that PVP delivers comparable clinical outcomes with substantially lower risks and complications, and shorter recovery times."
The company said the abstracts, which were written by prominent researchers and physicians from around the world, "confirm the significant benefits of PVP using the GreenLight laser system over other forms of BPH treatments," demonstrating improved healthcare costs through utilization of the PVP procedure; "substantial improvement" in safety over TURP, while providing equivalent efficacy; and the safety and effectiveness of PVP for a wide variety of patients.
Eric Reuter, president and CEO, said the number of abstracts presented at this year's meeting about the PVP procedure "is much higher than at any past conference, indicating a growing interest in PVP as a preferable alternative to many other forms of BPH treatment. We believe this year's presentations . . . show that PVP is quickly becoming the de facto standard of care for the treatment of BPH."
Indeed, the company has experienced explosive growth in PVP procedures. At its booth at the AUA, a slide indicated that first quarter 2005 procedures reached 16,255, or roughly 2.5 times the number of procedures performed in the first quarter of 2004.
Although Laserscope dominates the laser-based BPH market, Lumenis (Santa Clara, California) had an impressive presence at the meeting. The Lumenis laser, a holmium YAG, is different than Laserscope's. Some physicians assert is easier to use, and more importantly, it appears to be making progress in penetrating the market. It is ably assisted by Boston Scientific (Natick, Massachusetts), which is aggressively marketing its disposable laser fibers head to head against Laserscope.
With a strong presence and early lead, Laserscope appears positioned to continue to dominate in this area. Perhaps more importantly, the clinical and market success of these technologies is leading to the rapid demise of the previous gold standard for BPH, the TURP procedure.
Liam Hurley, MD and clinical professor of urology at Tufts University School of Medicine (Boston, Massachusetts), a speaker at the Lumenis booth, indicated his enthusiasm for laser-based procedures, stating that "in five years I think that the TURP procedure will be obselete."
Imaging powerhouse GE Healthcare (Waukesha, Wisconsin) launched the company's new Urology Suite, featuring the OEC UroView 2800 digital imaging system, to provide, it said, "GE's expertise in diagnostic and surgical imaging, ultrasound and information technologies for the complete urology care area."
The Urology Suite features ultrasound, fluoroscopy and endoscopic image quality, which can contribute to the improvement of surgical outcomes. GE said that increased up time in the cystoscopy suite, where clinicians evaluate the urethra and/or bladder for possible lesions, is a result of the company's dedicated service offering.
It added that increased connectivity allows for image access and review within the Urology Suite.
The total solution includes three products that GE said would "enhance physician efficiency and productivity for urological procedures." They include OEC UroView 2800, which the company characterized as "the market-leading urological digital imaging system"; LOGIQ Ultrasound, a high-performance ultrasound; andLOGIQworks, data management and multi-modality workstation.
The OEC UroView 2800 is a digital imaging system for cystoscopic/urological surgical and diagnostic procedures in which radiologic or endoscopic visualization also is needed. The new LOGIQ 5 Expert ultrasound system delivers the premium performance advantages of TruScan Architecture for unprecedented flexibility in acquiring, optimizing, and storing ultrasound studies. The company said LOGIQworks "is a breakthrough in data management for ultrasound systems, equipped with 3-D/4-D reconstruction and review, integrated raw data capability and robust DICOM support."
Also unveiling a new imaging solution was HealthTronics (Austin, Texas), showing the UroVantage, an intra-operative urological imaging system. The system features an Iso-centric C-arm with positioning flexibility beyond standard urology procedures, an all-digital imaging system and reduced radiation dose to patient and staff, head-to-toe imaging coverage on a 6'6" patient; and multipurpose functionality for general and orthopedic surgery, as well as gastrointestinal and vascular imaging.
CEO Brad Hummel said the technology offered with the UroVantage "offers . . . physicians and their patients a level of clinical care that far surpasses the competitive offerings available in the marketplace today." He said the new product "will pave the way for a substantial expansion of the company's medical device product line."
Misonix (Farmingdale, New York), a developer of ultrasonic medical device technology for the treatment of cancer and other healthcare purposes, and Focus Surgery (Indianapolis), a pioneer in the field of high-intensity focused ultrasound (HIFU), reported new system capabilities designed to reduce impotence in men and shorten prostate treatment times with the Sonablate 500, a device for the treatment of prostate cancer and benign prostatic hyperplasia (BPH).
The Sonablate 500 was developed by Focus Surgery and is distributed by Misonix in Europe and Russia. Misonix has an equity interest in Focus Surgery, manufactures the SB 500 and has an exclusive license to manufacture and sell a product using Focus Surgery's HIFU for the ablation of cancerous tissue in the kidney and liver.
The improved capabilities of the Sonablate 500 include new software and hardware using Doppler ultrasound to detect the neurovascular bundles controlling erectile function, along with advanced 3-D imaging and intensive energy delivery cycles with remote access capabilities.
The companies said the addition of Doppler ultrasound enables a physician to detect the neurovascular bundles for potency preservation during prostate cancer treatment. The 3-D imaging software converts the ultrasound images into 3-D model. The physician is then able to rotate, slice and separate prostate from the surrounding tissue for accurate HIFU treatment.
Narendra Sanghvi, president and CEO of Focus Surgery, said, "These novel additions to the Sonablate 500 will help physicians improve the treatment outcome."
The SB 500 is distributed by the major shareholders of Focus Surgery, including Takai Hospital Supply of Japan, which distributes the product in Asia; USHIFU (Charlotte, North Carolina), which distributes it in the Americas; and Misonix.
Dornier MedTech (Munich, Germany) introduced the Compact Delta II with UIMS, a lithotripsy system the company said "combines proven technology with special imaging, communication and reporting functionality."
The Compact Delta II is based upon the technology and performance of the Compact Delta. Dornier said the system delivers "exceptional stone-breaking ability" and offers treatment flexibility with a unique, motorized therapy head. The company said the isocentric design "allows imaging and targeting to revolve around a single focal point, making set-up and targeting precise and easy."
The fully digital Compact Delta II also features UIMS (Urology Information Management System), a patient data management system that incorporates comprehensive DICOM capabilities, including print, store, query/retrieve and worklist management. Dornier said the urology-based system can be integrated with other of its products, such as the Opus II or Doli S II, as well as any hospital network, allowing the user to exchange images from other modalities, including CT and ultrasound. Also available is the Advanced Patient Data Management Reporting System.
CEO Dave Eng said, "The addition of UIMS technology to the Compact Delta II adds another dimension to our line of lithotripters. The advanced imaging and networking capabilities make it ideal for any hospital or clinic."
Dornier MedTech specializes in lithotripters, urotables, orthopedic shockwave devices and medical-aesthetic lasers.
Siemens Medical Solutions (Malvern, Pennsylvania) introduced Lithoskop, a multifunctional lithotripter. The company said the new system is intended to increase efficiency for various urological applications, enhancing its comprehensive solution offerings.
Lithoskop features an ergonomic table and one-time patient positioning, and the digital interface can help clinicians with workflow and image management. Siemens said the system is the latest in its encompassing urology solution, which includes fixed and mobile lithotripsy and urology systems in addition to computed tomography, ultrasound and radiation therapy technology.
Lithoskop's design offers patient access from all sides, and a dual C-arm for X-ray imaging and shockwave head allow for multifunctional use and smooth workflow, according to the company. AutoPos, the system's computer-aided 3-D positioning tool, helps physicians align a patient's stone into focus, Siemens said. Once the stone is localized on the monitor, AutoPos automatically moves the table to position the stone for treatment.
Workflow benefits for digital reporting and patient management include DICOM Worklist, which allows for the downloading of patient data directly from a hospital's network, enabling newly generated images to be viewed, post-processed and stored immediately. And LithoReport is intended to aid workflow by allowing for detailed documentation of the entire therapeutic process. The Lithoskop is currently under clinical investigation.
Elsewhere on the exhibit floor:
Vivant Medical (Mountain View, California) said that data from a clinical study using its VivaWave Microwave Ablation system was presented during the meeting. An abstract titled "Phase II prospective evaluation of a novel microwave ablation system for renal masses during radical nephrectomy" presented results of a prospective, Phase II study of 10 patients with a solid, enhancing renal mass who underwent microwave ablation followed by radical nephrectomy either laparoscopically or through an open approach.
After nephrectomy, the ablated lesion was examined by visual inspection, by histopathology and NADH vital staining. The researcher presenting the study results concluded that "VivaWave can be utilized to generate reproducible large ablative lesions in solid renal neoplasms."
Millar Instruments (Houston), manufacturer of Mikro-Tip pressure transducer catheters and pressure-volume systems, reported a new exclusive domestic territory distributorship agreement with Life-Tech (also Houston). The arrangement allows Life-Tech to exclusively sell Millar's urology product line, while Millar will continue to handle all warranty and service items.
Millar's Mikro-Tip catheter pressure transducers for use by clinicians and medical researchers allows pressure measurements to be taken at the source, without time delay or motion artifacts. Demonstrations of the Millar catheters were featured in Life-Tech's booth.
NexMed (Robbinsville, New Jersey), a developer of transdermal treatments based on its NexACT drug delivery technology, reported the preliminary results from a 400-patient "at home" study conducted in China.
The multi-center study was designed to investigate the efficacy and safety of three strengths of Femprox cream in pre-menopausal and post-menopausal women diagnosed with female sexual arousal disorder (FSAD). Femprox is applied topically and incorporates alprostadil, a vasodilator, with the NexACT permeation technology.
Patients showed demonstrable improvement in sexual arousal over the course of therapy, with 38.7% of those who used the highest dose of Femprox showing an improvement at the end of the first evaluation period and 51.5% doing so at the end of the second evaluation period.