New Products: FDA approves treatment for complicated UTI

October 11, 2017

Other products and services discussed in this round-up include a biosimilar for cancer, an American College of Surgeons manual on quality initiatives, a kidney cancer microsite, and more.

 

FDA approves treatment for complicated UTI

The FDA has approved the combination of meropenem and vaborbactam (VABOMERE) for injection for the treatment of adult patients with complicated urinary tract infections (cUTI), including pyelonephritis, caused by designated susceptible Enterobacteriaceae-Escherichia coli,Klebsiella pneumoniae, and Enterobacter cloacae species complex. The combination therapy addresses gram-negative bacteria that produce beta-lactamase enzymes that have spread in the United States and Europe, particularly the Klebsiella pneumoniae carbapenemase enzyme. It is expected that the drug will be available in the fourth quarter of 2017, according to the Medicines Company.

For more information, go www.themedicinescompany.com/.

 

 

 

FDA approves first biosimilar for cancer, including mRCC

The FDA has approved MVASI (bevacizumab-awwb) for all eligible indications of the reference product, Avastin (bevacizumab). MVASI is the first anti-cancer biosimilar, as well as the first bevacizumab biosimilar, approved by the FDA, according to a joint statement from Amgen and Allergan plc. MVASI is approved for the treatment of five types of cancer, including metastatic renal cell carcinoma in combination with interferon alfa. MVASI is a biosimilar to bevacizumab, a recombinant immunoglobulin G1 monoclonal antibody that binds to vascular endothelial growth factor (VEGF) and inhibits the interaction of VEGF with its receptors, VEGF receptor-1 and VEGF receptor-2, thus inhibiting establishment of new blood vessels necessary for the maintenance and growth of solid tumors.

For more information, go to www.amgen.com/.

 

 

 

Endomicroscopy system allows visualization of tissue in real time

Cook Medical’s Urology business will begin distributing the Cellvizio Confocal Laser Endomicroscopy (CLE) System manufactured by Mauna Kea Technologies. With the Cellvizio system, a physician can visualize the internal microstructure of tissues in real time during ureteroscopic and cystoscopic procedures. CLE is an endoscopic technique that incorporates laser scanning technology to generate images of the internal microstructure of tissues. Cellvizio is a probe-based CLE system that uses Confocal Miniprobes, which are made up of optical fiber bundles and other optical elements. The probes transmit the laser energy to the tissue site and detect the fluorescent light that is reflected back. This reflected light is generated into real-time images of the internal microstructure of tissues. The Cellvizio system is composed of various components that are on a portable cart. This set-up allows the system to be transported between rooms in a hospital or clinic. The sterile probes used with the system can be reprocessed up to 20 times, depending on the model, according to Cook Medical.

For more information, go to www.cookmedical.com/.

 

 

 

ACS manual helps surgeons lead QI, patient safety efforts

The American College of Surgeons has released a new manual, Optimal Resources for Surgical Quality and Safety, to guide surgeons in leading surgical quality improvement and patient safety efforts in their institutions, departments, and practices. The manual delineates key concepts in quality, safety, and reliability and explores the essential elements that all hospitals should have in place to provide patient-centered care. Topics covered in the manual include the domains and phases of surgical care, the Surgical Quality Officer, and peer and case review.

For more information, go to www.facs.org/.

 

 

 

Updated glossary of infertility terms released

A new consensus-based and evidence-based document published simultaneously in Fertility and Sterility (2017; 108:393-406) and Human Reproduction contains 283 terms used in infertility and fertility care. Last revised in 2009, the glossary has been enhanced and expanded to facilitate better communication among health professionals, scientists, patients, policy makers, and the public. Notable changes in this edition of the glossary include the term “subfertility,” which may now be used interchangeably with “infertility;” and the definition of infertility as “a disease characterized by the failure to establish a clinical pregnancy after 12 months of regular, unprotected sexual intercourse or due to an impairment of a person's capacity to reproduce either as an individual or with his/her partner. […] Infertility is a disease, which generates disability as an impairment of function.”

For more information, go to www.asrm.org/.

 

 

 

NCCN journal launches dedicated kidney cancer microsite

The Journal of the National Comprehensive Cancer Network’s JNCCN360.org website recently launched a microsite specifically for kidney cancer. JNCCN 360 is a network of tumor-specific microsites that provides users with carefully curated content tailored specifically to NCCN’s audience. Tumor-specific content hosted on JNCCN 360 includes, but is not limited to, video discussions with clinical leaders, medical literature summaries, news briefs, and patient resources.

For more information, go to www.nccn.org/.

 

 

 

Mobile imaging devices emphasize convenience, versatility

Image Diagnostics offers two mobile urology imaging devices in MDS and UC Plus. The MDS is a mobile and camera centric imaging solution for urology as well as gastrointestinal and vascular procedures. It includes two 26" HD monitor displays. Fully-counterbalanced articulating arms allow easy manual positioning with up to 36” (91 cm) vertical travel and up to 81” (205.7 cm) horizontal extension. For convenience and ergonomics, images can be displayed over-the-table images in wide-screen, picture-in-picture, or split screen modes. The MDS accepts analog and digital signals from multiple sources including C-Arm, ultrasound, hemodynamics, microscopes, cameras, image guidance, PACS, and all image intensifier and flat detector fluoro technologies. The Aspect 100UC Plus is a full-function mobile urology table, featuring motorized four-way travel, elevation, and Trendelenburg Tilt. The UC Plus provides a large radiolucent imaging area for greater anatomic coverage and easy C-Arm access. With a 28”-wide tabletop, large patients can be safely positioned and supported up to the 525-pound capacity. The carbon fiber tabletop provides minimal x-ray attenuation over the entire imaging area. A built-in cassette tray and along with a wide assortment of urologic accessories provide for multi-purpose use in both x-ray imaging and general urologic procedures.

For more information, go to www.imagediagnostics.com/.

 

 

 

 

Additional 510(k) clearance granted for prostate MRI Marker

The FDA has granted an additional 510(k) clearance for the Sirius MRI Marker, a novel positive-signal MRI Marker that is used during the treatment of prostate cancer with brachytherapy. This additional 510(k) clears Sirius MRI Markers to be sterilized with ethylene oxide; previously, only gamma sterilization was available, according to manufacturer C4 Imaging LLC. The addition of ethylene oxide as an option increases convenience for customers and allows the benefits of MRI-assisted brachytherapy with Sirius to be made available to more prostate cancer patients, the company says.

For more information, go to www.c4imaging.com/.

 

 

Agreement reached for distribution of UTI, prostatitis tests

GenomeDx Biosciences and Pathnostics recently announced a strategic agreement for GenomeDx’s distribution of Pathnostics’ Guidance UGx and Guidance PRx, which are commercially available molecular diagnostic tests for urinary tract infections (UTIs) and prostatitis, respectively. GenomeDx will have exclusive distribution rights for Guidance UGx and Guidance PRx in most of the U.S. urology market, and Pathnostics will perform the testing at its CAP-accredited, CLIA-certified laboratory in Irvine, CA. Guidance UGx detects 25 microbial organisms associated with UTIs and determines the susceptibility of the infection to antibiotics considered for treatment. Guidance PRx detects 27 microbial organisms associated with acute prostatitis or chronic bacterial prostatitis and determines the susceptibility of the infection to antibiotics considered for treatment.

For more information, go to www.genomedx.com/.

 

 

 

Book outlines approach to understanding, overcoming burnout

“Save Yourself from Burnout: A System to Get Your Life Back” provides a comprehensive approach to understanding and overcoming burnout, according to publisher Bouclier Press. The book “leads each reader to identify the extent of their own burnout protection and vulnerability, creating a simple visual map to guide recovery and maintain their energy and passion for life," said co-author Beth Genly, MSN, who wrote the book with Marnie Loomis, ND.

For more information, go to www.burnout-solutions.com/.

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