(Press-News.org)
FEMSelect Ltd., a women-led company developing innovative technologies to make a lasting impact on women's health, today announced positive results from a large six-month safety and outcome study of EnPlace® in 123 women with pelvic organ prolapse, published in the International Journal of Gynecology & Obstetrics(IJGO).
The article, titled The EnPlace® sacrospinous ligament fixation—A novel minimally invasive transvaginal procedure for apical pelvic organ prolapse repair: Safety and short-term outcome results,1 discusses how investigators found that EnPlace, cleared by the FDA for attaching sutures to ligaments of the pelvic floor, is a safe and effective minimally invasive system for apical pelvic organ prolapse repair, either uterine or vaginal vault prolapse.
This large retrospective cohort study included 123 consecutive patients – ages 42 through 84 – with stage III and IV apical pelvic organ prolapse who underwent transvaginal sacrospinous ligament (SSL) fixation by EnPlace. Of the 91 (74%) patients with uterine prolapse, 83 (91.2%) patients experienced no recurrent uterine prolapse during the six-month follow-up. Of the 32 (26%) patients with preoperative vault prolapse, 30 (93.6%) experienced no recurrent vault prolapse.
These study results were presented during the 2023 International Urogynecology Association 48th Annual Meeting in The Hague, Netherlands, on June 22, 2023, by Ronen Gold, MD, faculty at the department of urogynecology, of the LIS Women’s Center Tel Aviv, Israel and a co-author on the study.
“EnPlace is proven as safe and effective in women affected by pelvic organ prolapse, and it is ideal for those seeking a minimally invasive procedure. FEMSelect is proud to offer solutions that dramatically improve outcomes for women, underscoring the need for innovation in women’s healthcare,” said Karla Loken, DO, FACOOG, chief medical officer of FEMSelect.
Authors of the study also reported that the patients who participated had no intraoperative or early postoperative complications. A median score of 87.3 was obtained (scale from 0 to 100) when patients were asked whether their preoperative symptoms were improved.
Professor Menahem Neuman, head of urogynecology at Raphael Hospital and Ben Gurion University, Beer Sheba, Israel, founder and medical director of FEMSelect, and an author of the study stated, “These positive results demonstrate that EnPlace can be considered for patients needing apical pelvic organ prolapse repair.”
Other study results showed that the EnPlace approach is particularly valuable in patients with comorbidities, such as patients with contraindications to general anesthesia, patients with a high probability of adhesions in the abdominal cavity or pelvis and patients for whom a transabdominal approach may pose technical difficulties.
About FEMSelect and The EnPlace® System
FEMSelect is a women-led company with a mission to make a lasting impact on women's health by delivering innovative technologies that provide consistent results in a patient-centric manner and dramatically improve outcomes for women. The EnPlace® system is a novel, minimally invasive device for transvaginal sacrospinous ligament fixation of pelvic organ prolapse, with no need for extensive dissection or mesh. For more information about the EnPlace® system, please contact info@femselect.com.
Reference:
Gold RS, Baruch Y, Neuman M, Sumerov N, Groutz A. The EnPlace® sacrospinous ligament fixation – A novel minimally invasive transvaginal procedure for apical pelvic organ prolapse repair: Safety and short-term outcome results. Int J Gynecol Obstet. 2023;00:1-5. doi:10.1002/ijgo.14927 END
Giving patients with operable pancreatic cancers a three-pronged combination immunotherapy treatment consisting of the pancreatic cancer vaccine GVAX, the immune checkpoint therapy nivolumab and urelemab, an anti-CD137 agonist antibody treatment, is safe, it increases the amount of cancer-killing immune system T cells in the tumors and it appears effective when given two weeks prior to cancer-removal surgery, according to new research directed by Johns Hopkins investigators. A description of the work was published online June 20 in the journal Nature Communications.
This study, led by researchers at the Johns Hopkins Kimmel Cancer Center, the Bloomberg~Kimmel ...
The nonprofit PhRMA Foundation launched a new grant program to provide more than $1 million in funding for research on the use of digital health technologies (DHTs) in underrepresented populations in clinical trials to advance regulatory decision-making.
Based on applicants’ letters of intent, the Foundation will award up to eight $25,000 planning grants to support the development of detailed research proposals to compete for two $500,000 grants. Planning grant award recipients will also be offered a $5,000 promotional credit from ...
Chestnut Hill, Mass. (7/17/2023) – Putting truth to the test in the “post-truth era”, Boston College psychologists conducted experiments that show when Americans decide whether a claim of fact should qualify as true or false, they consider the intentions of the information source, the team reported recently in Nature’s Scientific Reports.
That confidence is based on what individuals think the source is trying to do – in this case either informing or deceiving their audience.
“Even when people know precisely how accurate or inaccurate a claim of fact is, whether they consider that claim to be true or false hinges on the intentions ...
The vast scale of global trade presents a constant threat of introducing new plant diseases, which is challenging to the United States system of biosecurity. Plant health professionals often must respond quickly to a newly introduced or emerging plant disease outbreak even before a well-validated diagnostic test is available. Additionally, thousands of plant pathogens that already exist have been routinely diagnosed with assays that were not fully or consistently validated, which can lead to inaccurate diagnoses, delays in proper disease management, and significant consequences for growers and the public.
Growing awareness of this gap in coordination and resources for plant disease ...
Political apathy is growing in democracies around the world. Political apathy, also known as political alienation, describes feelings of separation and disaffection, a sense of powerlessness and an indifference to politics and political institutions. A hallmark of political alienation is a refusal to vote or participate in political activities. Adolescents and young adults are no exception to these trends. In many countries in Europe and North America, the youngest voters have the lowest participation rates.
Why are new voters so apathetic about politics? Many factors are ...
Ambitious global $1 billion per year ‘mission science’ model needed to win on sustainable development in time, warns experts
From the climate emergency and global health to the energy transition and water security, new report argues the global science and science funding efforts must be fundamentally redesigned and scaled up to meet complex needs of humanity and the planet.
July 17, 2023, NEW YORK – The current sustainability science model requires a fundamental redesign to keep up with the pace and complexity of the challenges facing the planet, argues the high-level ...
Ophiothrix angulata, a widely recognized and prevalent ophiuroid species in the Western Atlantic, has long been the subject of taxonomic debate due to its remarkable morphological diversity. A new study just published in PeerJ Life & Environment has shed light on the species' taxonomy, revealing a significant scientific breakthrough.
Led by a team of researchers from Universidad Nacional Autónoma de México, Universidad Católica del Maule and Florida Natural History Museum, the comprehensive study aimed to assess species delimitation ...
On the occasion of its annual general assembly in Singapore on 16 July 2023, the International Institute of Welding presented Sergio Amancio, from the Institute of Materials Science, Joining and Forming at Graz University of Technology (TU Graz), with this year’s Yoshiaki Arata Award in recognition of his scientific achievements. This award, consisting of a medal and a certificate, is considered one of the world’s most important awards for research in welding and additive manufacturing and usually goes to veteran researchers who are recognised for their life’s work. For ...
Statement Highlights:
The number of people who use electronic nicotine delivery systems, typically referred to as e-cigarettes, has grown exponentially, especially among youth and young adults. E-cigarette use more than doubled from 2017 to 2019 among middle and high school students.
Ingredients of e-cigarettes, including nicotine, flavoring agents, sweeteners and propylene glycol and vegetable glycerol, may each independently pose dangerous health risks.
More clinical studies on the long-term impact of e-cigarettes on the heart, blood vessels and lungs are needed, and experts emphasize additional molecular and laboratory research ...
In order for future mobility, such as urban air mobility (UAM), to become a reality, it must be fuel efficient and reduce carbon emissions, which requires the development of new materials with excellent physical properties and recyclability. Self-reinforced composites (SRCs) are inexpensive, lightweight, and have advantages in terms of disposal and recycling as the reinforcement and the base material are composed of the same material. For this reason, it is attracting attention as a next-generation composite material to replace carbon fiber-reinforced composites used in aircraft.
Korea Institute of Science and Technology (KIST, President ...
