A Medical Device Daily

The exhibit floor of the annual meeting of the American Urological Association (AUA; Baltimore) is upholding that gathering’s traditional stage for companies developing products for that broad treatment space to roll out their latest offerings.

This year’s meeting, which began Saturday and runs through Thursday at the Henry B. Gonzalez Convention Center in San Antonio, has seen numerous device firms calling attention to their new products or latest enhancements to existing products.

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), has 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 eighth new product being shown 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 2.4mm 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 is being unveiled at the AUA meeting for the first time. 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) said it has 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 plans to make the new features available to its current installed base through an upgrade program.

The company said the AUA meeting would feature 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 enlar-ged prostate.

Endocare 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 being 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.”

Elsewhere at AUA:

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.

“A Life-Tech/Millar partnership offers physicians two completely different types of universal urodynamic catheters. Two Houston-based urodynamic pioneers working together will have a synergistic effect on urodynamic product development as we move ahead,” said Lee McLeod, national sales director for Life-Tech.

Demonstrations of the Millar catheters are being featured in Life-Tech’s booth on the AUA 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.”