Fecal incontinence

Gastroenterology Group of Naples Introduces Innovative Axonics Sacral Neuromodulation Therapy

Retrieved on: 
Tuesday, March 19, 2024
Quality of life, Patient, Brain, Gastroenterology, Fecal incontinence, Communication, Hope, Medical device

NAPLES, Fla., March 19, 2024 /PRNewswire/ -- Gastroenterology Group of Naples, a partner practice of United Digestive, is pleased to announce the introduction of Axonics Sacral Neuromodulation Therapy to its list of advanced treatment options for those suffering from fecal incontinence. This innovative therapy involves a minimally invasive outpatient procedure in which a device is implanted that helps to restore normal communication between the brain and bowel by gently stimulating nerves. This nerve stimulation can result in symptom improvement.

Key Points: 
  • NAPLES, Fla., March 19, 2024 /PRNewswire/ -- Gastroenterology Group of Naples, a partner practice of United Digestive, is pleased to announce the introduction of Axonics Sacral Neuromodulation Therapy to its list of advanced treatment options for those suffering from fecal incontinence.
  • Dr. Rafael Urbina of the Gastroenterology Group of Naples explains that Axonics Therapy represents a significant advancement in the field of gastroenterology.
  • "At Gastroenterology Group of Naples, we are committed to staying at the forefront of medical innovation to ensure that our patients receive the highest standard of care.
  • For more information about Gastroenterology Group of Naples and Axonics Therapy, please visit uniteddigestive.com and Axonics.com .

Axena Health Announces New HCPCS Code Supporting Coverage for the Leva Pelvic Health System

Retrieved on: 
Monday, March 4, 2024
Health, FDA, Medical Devices, Consumer, Women, Health Technology, General Health, UI, Woman, Manager, CMS, Quality of life, Female, Urinary incontinence, Fecal incontinence, Risk, Leva, Disability, Medicare, Incontinence, Patient, HCPCS, Privacy, Medicaid, PFMT, Insurance, Birth control

Axena Health, Inc. (Axena Health), a medical device company focused on female pelvic health, welcomes the Centers for Medicare & Medicaid Services’ (CMS) new Healthcare Common Procedure Coding System (HCPCS) Level II code for the Leva® Pelvic Health System.

Key Points: 
  • Axena Health, Inc. (Axena Health), a medical device company focused on female pelvic health, welcomes the Centers for Medicare & Medicaid Services’ (CMS) new Healthcare Common Procedure Coding System (HCPCS) Level II code for the Leva® Pelvic Health System.
  • The Leva System’s new HCPCS Level II code simplifies access for patients, eliminating barriers that can delay coverage through their insurance plan.
  • The Leva System’s HCPCS code along with its previously established pharmacy code, make either channel an option to increase access through insurance.
  • And this new code is a huge step towards making the Leva System available to all women who need symptom relief.”

Axena Health Studies Barriers to First-Line Treatment for Urinary Incontinence

Retrieved on: 
Monday, January 22, 2024
Health, Medical Devices, Consumer, Women, Health Technology, Seniors, Physical Therapy, Woman, Patient, Policy, Female, Fecal incontinence, PFMT, Urinary incontinence, Incontinence, Menopause, UI, Pelvic floor, Nursing

Axena Health, Inc. (Axena Health), a medical device company focused on female pelvic health, has launched a study to examine the barriers women faced while seeking treatment for urinary incontinence (UI) and fecal incontinence (FI).

Key Points: 
  • Axena Health, Inc. (Axena Health), a medical device company focused on female pelvic health, has launched a study to examine the barriers women faced while seeking treatment for urinary incontinence (UI) and fecal incontinence (FI).
  • Study results could help clinicians, payers and policy makers accelerate access to easy, effective first-line treatment for UI and FI.
  • “Professional societies and medical guidelines recommend conservative, first-line treatment for urinary and fecal incontinence,” said Eileen Maus, Axena Health’s CEO.
  • My hope is that our study will help us better understand the patient journey and the barriers to first-line, conservative care.”
    62% of U.S. adult women live with UI .

Axena Health welcomes 4 distributors for the Leva Pelvic Health System

Retrieved on: 
Tuesday, January 9, 2024
Women, Seniors, General Health, Health, Medical Devices, Consumer, Clinical Trials, Other Health, Woman, Patient, NAFC, Continence, Female, Fecal incontinence, PFMT, Urinary incontinence, Embarrassment, Kegel exercise, Quality of life, Incontinence, Accidental, National Association for Continence, UI, FDA, Doctor of Philosophy, Shame, Pelvic floor, Physician

Axena Health, Inc. (Axena Health), a medical device company focused on female pelvic health, has signed agreements with four leading distributors to streamline access to the Leva® Pelvic Health System.

Key Points: 
  • Axena Health, Inc. (Axena Health), a medical device company focused on female pelvic health, has signed agreements with four leading distributors to streamline access to the Leva® Pelvic Health System.
  • While UI and FI are the most prevalent pelvic floor disorders among women, they are vastly undertreated.
  • The Leva System makes PFMT accessible by supporting a women’s success as she improves her incontinence symptoms.
  • "Pelvic floor muscle training is a globally recommended solution that Leva makes more accessible to women.

Teleflex Completes Acquisition of Palette Life Sciences

Retrieved on: 
Tuesday, October 10, 2023
NYSE, Acquisition, EPS, Rectum, Vesicoureteral reflux, Radiation, Teleflex, Fecal incontinence, TFX, Prostate cancer, Palette

WAYNE, Pa., Oct. 10, 2023 (GLOBE NEWSWIRE) -- Teleflex Incorporated (NYSE:TFX), a leading global provider of medical technologies, today announced that it has completed the previously announced acquisition of Palette Life Sciences AB.

Key Points: 
  • WAYNE, Pa., Oct. 10, 2023 (GLOBE NEWSWIRE) -- Teleflex Incorporated (NYSE:TFX), a leading global provider of medical technologies, today announced that it has completed the previously announced acquisition of Palette Life Sciences AB.
  • The acquisition adds Barrigel®, a biodegradable sculptable rectal spacer, to Teleflex’s Interventional Urology portfolio.
  • On July 26, Teleflex announced its entry into a definitive agreement to acquire Palette.
  • The acquisition is expected to be approximately $0.25 dilutive to adjusted earnings per share (excluding non-recurring purchase accounting items and other acquisition and integration related costs) in 2023.

PFD Week Abstracts Show Leva’s Long-Term Treatment Value for Female Urinary Incontinence Plus New Data for Other Pelvic Floor Disorders

Retrieved on: 
Friday, October 6, 2023
Medical Devices, Health, Consumer, Hospitals, Women, Clinical Trials, The Green Journal, Nursing, Food, Female, Doctor of Philosophy, Abstract, Research, Prevalence, Urinary incontinence, PFMT, MD, Randomized controlled trial, Insurance, PFD, University, Massachusetts General Hospital, Hospital, Storey, Pelvic floor, Pelvic organ prolapse, FDA, Incontinence, FI, Harvard Medical School, POP, Vagina, Fecal incontinence, RCT, UI, Regulation of tobacco by the U.S. Food and Drug Administration, Woman, Richter, Quality of life, Birth control, Pharmaceutical industry, Dietary supplement, Gynaecology, Obstetrics

The Leva System is a non-drug, non-surgical treatment that helps women strengthen their pelvic floor at home, on their own schedule, by guiding correct and consistent pelvic floor muscle training (PFMT).

Key Points: 
  • The Leva System is a non-drug, non-surgical treatment that helps women strengthen their pelvic floor at home, on their own schedule, by guiding correct and consistent pelvic floor muscle training (PFMT).
  • The researchers presented their data in two abstracts during PFD Week 2023, the American Urogynecologic Society’s (AUGS) annual scientific meeting held in Portland, Ore. Oct. 4-6, 2023.
  • “We do, and it provides powerful validation of the Leva Pelvic Health System’s treatment value for women.
  • The research also showed that women with multiple pelvic floor disorders had more severe UI symptoms than women with UI only.

Teleflex to Acquire Palette Life Sciences

Retrieved on: 
Wednesday, July 26, 2023
Marketing, TRUS, TFX, Fecal incontinence, LRP, Incidence, Vesicoureteral reflux, Acquisition, Rectum, Patient safety, Urology, Growth, FDA, Health, Hand, NYSE, Prostate cancer, Pharmaceutical industry, Medical imaging, Teleflex

Palette Life Sciences is estimated to generate net sales of approximately $56 million, on a standalone basis, in 2023.

Key Points: 
  • Palette Life Sciences is estimated to generate net sales of approximately $56 million, on a standalone basis, in 2023.
  • “The acquisition of Palette Life Sciences will allow us to incorporate this exciting technology into our Interventional Urology business unit and bring urologists, radiation oncologists, and other specialists more innovative technologies that can positively impact patient care.
  • We believe Palette Life Sciences will be a meaningful contributor to our growth in the coming years.
  • The Palette Life Sciences portfolio also includes Deflux® and Solesta®, which are NASHA based tissue bulking agents designed to treat pediatric vesicoureteral reflux and fecal incontinence, respectively.

Axena Health delivers at-home treatment for chronic fecal incontinence in women

Retrieved on: 
Tuesday, June 20, 2023
Biotechnology, Medical Devices, Other Health, Health, Health Technology, Depression, Femtech, UI, European Journal of Obstetrics & Gynecology and Reproductive Biology, PFMT, The Green Journal, RCT, Quality of life, Incontinence, Woman, Guilt, Research, FACOG, Medicine, Leva, Associate, Reproductive biology, Harvard Medical School, Fecal incontinence, Feces, Shame, MD, Patient, Social stigma, Social isolation, Frustration, ABL, Chairperson, FACS, FDA, Massachusetts General Hospital, Pelvic floor dysfunction, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Female, Urinary incontinence, Birth control, Pharmaceutical industry, Obstetrics, Gynaecology

Axena Health, Inc. (Axena Health), a FemTech medical device company focused on scalable treatments for female pelvic health, introduced today the Leva®Pelvic Health System for the first-line treatment of chronic fecal incontinence (FI), also called accidental bowel leakage (ABL), in women.

Key Points: 
  • Axena Health, Inc. (Axena Health), a FemTech medical device company focused on scalable treatments for female pelvic health, introduced today the Leva®Pelvic Health System for the first-line treatment of chronic fecal incontinence (FI), also called accidental bowel leakage (ABL), in women.
  • In our study, we showed that the Leva System had the potential to improve fecal incontinence symptoms, which gives both clinicians and women an easy, practical way to access first-line treatment.
  • “Pelvic floor muscle training is a first-line treatment for both urinary and fecal incontinence,” said Samantha Pulliam, MD, FACOG, chief medical officer for Axena Health.
  • Thousands have used it to relieve symptoms of urinary incontinence, and we aspire to saying the same for women who experience fecal incontinence.

CELLF BIO Achieves Milestone With First In Human Implantation of BioSphincter™

Retrieved on: 
Tuesday, June 6, 2023
Clinical trial, FI, Cell, Stem cell, Embarrassment, Colon, Fecal incontinence, AGAF, Patient, Social isolation, NIH, Pharmaceutical industry, Doctor of Philosophy

RICHMOND, Va., June 06, 2023 (GLOBE NEWSWIRE) -- CELLF BIO achieved a major milestone with the world's first human implantation of BioSphincter™, an autologous bioengineered sphincter made of smooth muscle and differentiated neural stem cells.

Key Points: 
  • RICHMOND, Va., June 06, 2023 (GLOBE NEWSWIRE) -- CELLF BIO achieved a major milestone with the world's first human implantation of BioSphincter™, an autologous bioengineered sphincter made of smooth muscle and differentiated neural stem cells.
  • The implantation surgery was performed by Dr. Jaime Bohl, chief of colon and rectal surgery at the Virginia Commonwealth University School of Medicine in Richmond, Virginia.
  • "We are very pleased with the progress of the clinical trial thus far," said CELLF BIO CEO Dr. Khalil N. Bitar, PhD, AGAF.
  • CELLF BIO has been selected to present for the NIH booth at the BIO International Convention June 6th, 2023.

Axena Health Begins First-of-Its-Kind Global Study of Female Incontinence

Retrieved on: 
Wednesday, May 17, 2023
Health, Medical Devices, Consumer, Women, General Health, Pharmaceutical, Biotechnology, Well, AXA, PFMT, FI, Cigna, Fecal incontinence, Mother, MD, Disease, Society, GAVI, Johnson, Urinary incontinence, Bill & Melinda Gates Foundation, The Green Journal, Health equity, Ageing, Hope, Innovation, Research, UNICEF, Government, MS, Local government in Nepal, Organization, DPT, Equality, RCT, Johns Hopkins University Center for Communication Programs, BOSCH, Incontinence, Global Health, Ministry, Ministry of Health (Singapore), World Health Organization, United, MPH, Fistula, Family, UI, Woman, Leva, Female, Pharmaceutical industry, Nursing, Gynaecology, MBBS, Obstetrics

Axena Health, Inc. (Axena Health), a women’s health medical device company focused on scalable treatments for female pelvic health, announced today a large-scale study that will investigate the burdens of incontinence on women in low- and middle-income countries to support equitable access to treatment.

Key Points: 
  • Axena Health, Inc. (Axena Health), a women’s health medical device company focused on scalable treatments for female pelvic health, announced today a large-scale study that will investigate the burdens of incontinence on women in low- and middle-income countries to support equitable access to treatment.
  • “Urinary incontinence is a global health problem,” said Jessica McKinney, DScPT, MS, co-author of ‘ Implementing Physical Rehabilitation Services into Comprehensive Fistula and Maternity Care: A Training Guide for Health Workers ’, and Axena Health’s VP of Clinical Affairs and Global Health.
  • The burden of incontinence is gendered, and the costs borne by individuals and societies is multifactorial,” said Laura Keyser, DPT, MPH, co-author of the aforementioned Training Guide, and Director of Clinical Strategy and Global Health at Axena Health.
  • “Female incontinence is a significant unmet health need for millions of women worldwide, and we believe we’re uniquely able to help,” said Eileen Maus, CEO of Axena Health.