Other products discussed include a stent system for treating ureteral obstructions, a male infertility test, and more.
Marlborough, MA-Boston Scientific has announced the U.S. and European launch of the Dakota Nitinol Stone Retrieval Device with OpenSure Handle, a kidney stone retrieval device that enables physicians to release and capture kidney stones ranging in size from 1 to 10 ml. The OpenSure Handle is designed to release a larger stone, while the nitinol hybrid grasper basket allows a physician to capture, reposition, and remove multiple stones and small fragments in the same procedure. The three-arm nitinol hybrid basket is designed to open and close at full deflection to help physicians reach stones in challenging anatomic locations, according to Boston Scientific. The device was launched at the 34th World Congress of Endourology conference in Cape Town, South Africa.
For more information, visit www.bostonscientific.com.
Mountain View, CA-Brightwater Medical, Inc. has received FDA clearance for its ConvertX Nephroureteral Stent System to treat ureteral obstructions. Unlike traditional stent procedures, the ConvertX System does not require interventional radiologists to perform a second invasive procedure to exchange a nephrostomy catheter for an internal ureteral stent to circumvent the blockage. The system is converted from a catheter to a stent in a brief office procedure without the need for sedation or radiation and remains implanted in the patient like a standard internal ureteral stent. In addition to the FDA clearance, Brightwater also received a medical device manufacturing license from the California Department of Public Health for the ConvertX System.
For more information, visit www.brightwatermed.com.
Salt Lake City-Episona has launched a male fertility test, Seed, that evaluates epigenetic changes on DNA to predict the risk for male factor infertility and poor embryo development. The physician-ordered test is offered in a simple fertility kit for use at home or in a fertility clinic. The sample is sent to a CLIA-certified lab for analysis and physicians receive a detailed report on the patient’s risk of male factor infertility within 2 weeks. The improved understanding of the patient’s situation can help the physician recognize which route would be best for the patient, whether that be spending time on less-invasive procedures, such as intrauterine insemination, or to look directly at in vitro fertilization (IVF). Seed also identifies problems and can provide clarification if an IVF cycle fails or, in the case of seeking a donor, if a male or female donor would be preferred. The test has been evaluated in two clinical studies, with both studies demonstrating correlations between epigenetic abnormalities and male factor infertility. Seed is initially being launched in the United States as a laboratory-developed test.
For more information, visit www.episona.com.
Pitman, NJ-The Society of Urologic Nurses and Associates (SUNA) has released the first comprehensive core curriculum for urologic nurses and professionals in all stages of their career. The first edition of the hybrid text is peer reviewed, evidence based, and applicable to urologic nurses working in both general pediatric or adult urology practice. In addition to clinical content, the curriculum also acts as a resource for promoting urologic health. Some of the available chapters focus on genitourinary cancers, sexually transmitted infections, sexual dysfunction, and incontinence.
For more information, visit www.suna.org.
Silver Spring, MD-The FDA has approved the once-daily vaginal insert, prasterone (Intrarosa), for the treatment of moderate to severe pain during sexual intercourse in women as a symptom of vulvar and vaginal atrophy (VVA) due to menopause. The efficacy of the drug was established in two 12-week, placebo-controlled clinical trials of 406 healthy postmenopausal women. The women in the study ranged from 40 to 80 years old and all complained of moderate to severe pain during sexual intercourse as their most vexing symptom of VVA. The safety of the insert was established in four 12-week placebo-controlled trials and one 52-week open-label trial. The most common adverse reactions were vaginal discharge and abnormal Pap smear. Intrarosa is being marketed by Endoceutics, Inc.
For more information, visit www.endoceutics.com.
Irvine, CA-MDxHealth announced that Health Care Services Corp. (HCSC) has issued coverage for patients who meet the eligibility requirements established under the positive medical policy for the company’s tissue-based test, ConfirmMDx for Prostate Cancer. HCSC, an independent licensee of the Blue Cross and Blue Shield (BCBS) Association serving five states, is the largest customer-owned health insurer in the United States and fourth-largest health insurer overall. ConfirmMDx for Porstate Cancer, a tissue-based and epigenetic test, provides a high negative predictive value (NPV) of 96% for clinically significant prostate cancers and 90% NPV for all prostate cancers. Previously, MDxHealth announced that Highmark, the fourth largest BCBS-affiliated company, also issued a positive medical coverage policy decision for the ConfirmMDx test.
For more information, visit www.mdxhealth.com.
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