product approval

Axonics® Receives IDE Clearance from US FDA to Conduct Pivotal Study

Axonics Modulation Technologies, Inc., developer of the first rechargeable sacral neuromodulation (r-SNM™) system for the treatment of overactive bladder (OAB) and bowel dysfunction, today announced the U.S. Food & Drug Administration (FDA) has granted an Investigational Device Exemption (IDE) in accordance with 21 CFR 812 regulations allowing Axonics to conduct a pivotal study designed to gain FDA approval in the United States.  “During 2017, as part of the IDE process, the FDA conducted a significant review of our product. A major focus of the technical review was the long-term safety of our implant. The fact that we were able to support our anticipated 15-year full system life-in-the-body claim based on our robust design and development processes, risk analysis and extensive validation testing is testament to the high-quality work of our team,” said Raymond W. Cohen, Chief Executive Officer of Axonics. “Given the demand in the U.S. market for SNM therapy, gaining FDA approval is our main focus. To that end, we fully intend to execute this well-designed pivotal study with velocity and in the best interests of patients.” Read more.

Source: Pharmaweb, November 7, 2017

Apple iPhone

Crohn’s and Colitis Canada Wants Businesses to Open Their Washrooms to Those In Need

Crohn’s and Colitis Canada is taking aim at a serious hurdle many Canadians with Crohn’s disease or ulcerative colitis face – accessing washrooms on the go. November is Crohn’s and Colitis Awareness Month, and the national charity is advocating that public washroom access is a right, not a privilege, and for the Canadians living with these chronic diseases, it’s a critical need.  Crohn’s and colitis are debilitating, yet often invisible, autoimmune diseases. They cause the body to attack healthy tissue, leading to the inflammation of all or part of the digestive tract. Symptoms include diarrhea, internal bleeding, and abdominal pain, and result in the frequent and urgent need to use the washroom, in some cases over 20 times a day.  Read more.

Source: CNW, November 1, 2017

obese, obesity

Study Highlights Association of Obesity with Fecal Incontinence in Spina Bifida Patients

In the November 2017 issue of Diseases of the Colon and Rectum, Dr. Charlène Brochard and her colleagues from a spina bifida referral center in Rennes, France, report on the frequency of intestinal problems in 26- to 45-year-old patients with spina bifida. The multidisciplinary study included clinical data obtained over a 9-year period on nearly 400 spina bifida patients, emphasizing the association of obesity with fecal incontinence and bowel dysfunction.  Read more.

Source: News-Medical. net, October 9, 2017

clostridium difficile

Consure Medical Improves Ease-of-Use & Comfort of Patients with FI

You may not think that the topic of fecal incontinence (FI) and management sounds very lucrative or interesting, and within demanding and stressful healthcare environments it is usually last to receive attention. Even if healthcare workers do think about these issues, they often do not have as much time as they would like to invest in fecal management, and they have had few options to choose from until now.  Consure Medical has developed Qora, a novel stool management kit, that not only improves management, patient care, and provides ease of use with no compromise of patient safety, but it also greatly reduces overall hospital stay and associated costs. Qora can greatly reduce the incidence, occurrence, and the costs associated with hospital acquired conditions (HACs), including nosocomial infections such as C. diff, Catheter-Associated Urinary Tract Infections (CAUTI), Central Line-Associated Bloodstream Infection (CLABSI), and hospital-acquired pressure injury (HAPI), in comparison to the traditional practices of FI management.  Read more.

Source: medGadget, September 15, 2017

medical research

RDD Pharma Awarded CDMRP Grant for Clinical Drug for SCI Patients

RDD Pharma, a leader in developing treatments for anorectal disorders, announced today the Department of Defense office of the Congressionally Directed Medical Research Programs (CDMRP) has funded the Spinal Cord Injury Research Program (SCIRP) Translational Research Award – Clinical Trial application.  The grant of $1.28M will enable initial U.S. clinical development of RDD-0315 for fecal incontinence in spinal cord injury patients including preparations for and conducting of a Phase 1 study in healthy volunteers to assess acute tolerance and PK.  “We are pleased the CDMRP recognized the clinically significant benefit that RDD-0315 may offer spinal cord injury patients,” stated Jason Laufer, Chief Executive Officer, RDD Pharma.  “We can now move forward more aggressively in the U.S. to develop RDD-0315 which has the potential to positively impact the health, well-being and quality of life in this patient population.”  Read more.

Source: PRNewswire, September 14, 2017

microbiologist at laboratory work

Lab-engineered Tissue Is Creating New Digestive Tract Treatments

Wake Forest Baptist Medical Center have reported success with lab-engineered tissue replacements to treat digestive system diseases.  The research team demonstrated the effectiveness of growing anal sphincters in a lab to treat an animal model for fecal incontinence. The success comes after the researchers reported success in implanting human-engineered intestines in rodents.  “Results from both projects are promising and exciting,” said Khalil N. Bitar, senior researcher on both projects, in a press release. “Our goal is to use a patient’s own cells to engineer replacement tissue in the lab for devastating conditions that affect the digestive system.”  Read more.

Source: Medical Design & Outsourcing, August 10, 2017

stem cells

Engineering Digestive System Tissues: Significant Progress

Researchers at Wake Forest Institute for Regenerative Medicine have reached important milestones in their quest to engineer replacement tissue in the lab to treat digestive system conditions — from infants born with too-short bowels to adults with inflammatory bowel disease, colon cancer, or fecal incontinence.  Reporting today in Stem Cells Translational Medicine, the research team verified the effectiveness of lab-grown anal sphincters to treat a large animal model for fecal incontinence, an important step before advancing to studies in humans. And last month in Tissue Engineering, the team reported success implanting human-engineered intestines in rodents. Read more.

Source: Science Daily, July 5, 2017

business buildings

RDD Pharma Receives Orphan Designation for RDD-0315 in Spinal Cord Injury Patients

RDD Pharma, a leader in developing treatments for anorectal disorders, announced today the European Medicines Agency’s Committee for Orphan Medicinal Products has granted orphan designation for RDD-0315, an investigational drug for the treatment of fecal incontinence in patients with spinal cord injury.   The committee recognized that RDD-0315 may be of significant benefit to spinal cord injury patients affected by fecal incontinence. “We are pleased the EMA recognized the clinically significant benefit that RDD-0315 may offer spinal cord injury patients,” stated Jason Laufer, Chief Executive Officer, RDD Pharma.  ‘We have the potential to positively impact the health, well-being and quality of life in this patient population. ‘  Read more.

Source: PRNewswire, July 5, 2017

 

Christine Norton, PhD

2017 John J. Humpal Award Presented to Professor Christine Norton at Innovating for Continence Conference

The John J. Humpal award was presented to Professor Christine Norton at the Simon Foundation for Continence’s sixth biennial Innovating for Continence: The Engineering Challenge conference, hosted April 19-21 at the Millennium Knickerbocker Hotel, in Chicago, IL, USA.

Christopher Payne, MD, Emeritus Professor of Urology at Stanford University presented the John J. Humpal award to Christine Norton, PhD, MA, RN. Dr. Payne asked the conference attendees, “What makes a young, talented nurse scientist choose the field of fecal incontinence? While I don’t have the exact answer to that question, we are certainly lucky that she did. I first met Christine at the WHO International Consultation on Incontinence in 2005 and was struck by the clarity and insightfulness of her committee’s findings. Christine achieved the classic goal for medical faculty with major contributions in teaching, education, and clinical care. In fact, there is practically nothing in the entire field to which she has not contributed. For this she was awarded an endowed professorship. I’m a bit jealous, but very proud to be her colleague, and to present her this well-deserved award.”

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clostridium difficile

ConvaTec Releases New Fecal Management System in US

Global medical technology company ConvaTecGroup announced the US launch of the Flexi-Seal PROTECT Fecal Management System on Tuesday, following receipt of 510(k) clearance from the US Food and Drug Administration.  The FTSE 100 firm said Flexi-Seal PROTECT FMS was the latest addition to the company’s “market-leading range” of advanced systems developed to manage acute fecal incontinence, and help to reduce the associated risks of skin breakdown and spread of C. difficile infection.  Read more.

Source: digitallook.com, May 2, 2017