New Products: Two-in-one wire device combines access, safety guides

Two-in-one wire device combines access, safety guides

Cook Medical has introduced the Motion Hybrid Wire Guide, a two-in-one wire guide. The wire guide merges the strengths of a Teflon fixed core wire guide and a nitinol access wire guide into a single device. The device allows surgeons to simplify their procedures by reducing the number of wire guide exchanges during a procedure, according to Cook. The product also may help consolidate inventory in some cases because stocking a separate access wire guide and safety wire guide is no longer necessary. The core of the Motion Hybrid Wire Guide is nitinol, while the body of the wire guide is Teflon coated.

For more information, visit www.cookmedical.com.

Updated prostate tissue ablation device receives 510(k) clearance

SonaCare Medical has received 510(k) regulatory clearance to market the latest version of its prostate tissue ablation device, Sonablate. The improved version includes updates and new features including Tissue Change Monitoring (TCM), which quantifies radiofrequency signals for changes in tissue composition following energy delivery. It also features an altered delivery sequence that reduces overall procedure time by as much as 40%, according to SonaCare. The look and software interface have also been updated.

For more information, visit www.sonacaremedical.com.

Contrast agent for voiding ultrasonography earns FDA approval

Bracco Diagnostics Inc. has received FDA approval for its contrast agent, Lumason, for use in ultrasonography of the urinary tract (voiding ultrasonography) for the evaluation of vesicoureteral reflux (VUR) in pediatric patients. The approval answers an unmet medical need for an effective imaging study to detect and follow-up VUR without exposing pediatric patients to potential harms of ionizing radiation, according to Bracco Diagnostics. The contrast agent is composed of gas-filled microspheres and is packaged in a three-part portable kit that does not require refrigeration or mechanical agitation. In 2015, the Centers for Medicare & Medicaid Services granted Lumason “pass-through” status for Lumason reimbursement under the Hospital Outpatient Prospective Payment System.

For more information, visit http://imaging.bracco.com/us-en.

Micro-ultrasound system receives 510(k) clearance

The FDA has awarded 510(k) clearance to ExactVu, a micro-ultrasound system from Exact Imaging. The product, a disruptive prostate micro-imaging and biopsy system, can provide urologists with real-time imaging and biopsy guidance of the prostate. It represents a 300% improvement in imaging resolution–resolution can be scaled down 70 microns (or 0.07 of a millimeter)–compared to traditional urologic ultrasound systems, according to Exact Imaging. The product is designed to facilitate the detailed interrogation and visualization of suspicious regions and perform targeted prostate biopsies, the company says.

For more information, visit www.exactimaging.com.

LUGPA launches consulting service for practices

LUGPA Healthcare Consulting Services, a new subsidiary of LUGPA (formerly the Large Urology Group Practice Association) that has been launched to provide its members with urology-centric information and services. The service can help urology practices prepare and improve their business aspects, including preparing for mergers and consolidation, provide advice on health care rules and regulations, and offer strategies to improve performance. The LUGPA Healthcare Consulting Services’ advisers consist of a group of more than 20 LUGPA members.

For more information, visit www.LUGPAConsulting.com.

Bladder Ca test identifies those at low risk of recurrence

Pacific Edge Ltd. has launched its bladder cancer test, Cxbladder Monitor, in the United States. The noninvasive test is designed to be used as part of patients’ ongoing surveillance regimen to identify those who have a low probability of having recurrent cancers. Based on test results, patients may not need a cystoscopy or other invasive workup or can increase the intervals between invasive workups, according to Pacific Edge. Pacific Edge also offers the Cxbladder Triage, which helps to rule out cancer in patients who have a low probability of having bladder cancer, and Cxbladder Detect, which is used to specifically detect bladder cancer. A fourth test, for identifying patients with high-grade and late-stage bladder cancer, is expected to launch in the U.S. in 2017.

For more information, visit www.pacificedgedx.com.

Updated lap/robotic surgery text includes new chapters, videos

Elsevier has published the third edition of the “Atlas of Laparoscopic and Robotic Urologic Surgery” textbook. Written by Jay T. Bishoff, MD, Louis R Kavoussi, MD, MBA, and David A. Leavitt, the third edition has been revised and expanded to include several new additions. There are 20 new chapters on camera and lens systems, instrumentation, robot-assisted and laparoscopic simple prostatectomy, and the da Vinci surgical system. Chapters on laparoscopic partial nephrectomy and endoscopic inguinal lymph node dissection for penile cancer have been revised and updated. Thirty high-quality videos have been added online, providing more than 3 hours of video instruction. The Expert Consult eBook version is included with purchase, which allows the reader to search all of the text, figures, Q&As, and references from the book.

For more information, visit www.elsevierhealth.com.