Navigation Links
Synapse Biomedical Receives FDA Humanitarian Use Device Designation for Amyotrophic Lateral Sclerosis (ALS)
Date:10/8/2010

,000 people in the United States live with ALS. More than 5,000 new cases are diagnosed each year, with an estimated subset of 3,300 with both chronic hypoventilation and intact phrenic nerves that could potentially benefit from treatment with the NeuRx DPS™.  

In ALS, the NeuRx DPS™ provides electrical stimulation to the diaphragm muscles and continues to exercise the muscles, in an attempt to delay diaphragm atrophy and the need for invasive mechanical ventilation.  NeuRx DPS™ stimulates the diaphragm, causing a contraction that mimics natural breathing.

"In our efforts to help people with this devastating disease, we are using and focusing every available resource to help advance the availability of the NeuRx treatment.  Having obtained HUD designation and filed our HDE application for ALS, we will now seek Continued Access approval for our clinical trial centers," said Anthony R. Ignagni, Synapse President and Chief Executive Officer.  Continued Access (CA) is an Office of Device Evaluation (ODE) policy that permits sponsors of clinical investigations to continue to enroll subjects while a marketing application is being reviewed by the ODE.  The ODE grants CA based on a public health need for the device or if there is preliminary evidence the device is likely to be effective and no significant safety concerns have been identified for the proposed indication.

In the United States, the NeuRx DPS™ received investigational device status in October 2005 for use in a clinical trial for ALS. The following clinical sites were approved to participate in NeuRx DPS™ clinical testing for ALS:

  • University Hospitals Case Medical Center, Cleveland, Ohio
  • Johns Hopkins, Baltimore, Md.
  • Stanford University, Stanford, Calif.
  • Methodist Neurological Institute, Houston, Texas
  • Henry Ford Health System, Detroit, Mich.
  • Mayo Clinic,
    '/>"/>

SOURCE Synapse Biomedical Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. Synapse Biomedical Receives FDA Approval of NeuRx Diaphragm Pacing System (DPS)(TM) For Spinal Cord Injury Breathing Applications
2. Four Alzheimers Clinical Trials Address a Variety of Treatment Targets - Amyloid, Tau, Synapse Formation
3. BHR Pharma Announces Phase 3 SyNAPSe Study of Progesterone as a Neuroprotective Agent for Traumatic Brain Injury
4. FUJIFILM Europe Teams Synapse with Matrox Xenia
5. With Virtualized Synapse Portfolio Clarian Increases Efficiency, Decreases Cost
6. Proventix™ Partners with Synapse Wireless to Save Lives
7. BHR Pharma Enrolls First Patient in Phase 3 SyNAPSe Traumatic Brain Injury Trial
8. Boston University Biomedical Engineers Find Chink in Bacterias Armor
9. Nobel Prize Awarded to Foundation for Biomedical Research Board Member
10. Saladax Biomedicals 5-FU Personalized Chemotherapy Management (PCM(R)) Assay CE Marked for Distribution in the EU
11. The Foundation for Biomedical Research Announces Winners of the 7th Annual Michael E. DeBakey Journalism Awards
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/11/2014)... -- Research and Markets ( http://www.researchandmarkets.com/research/tjlw9k/immunoprotein ) has ... Testing Market - Forecasts to 2019: Expected to ... is expected to be valued at USD 4,943.0 ... http://photos.prnewswire.com/prnh/20130307/600769 The ... according to immunoprotein types which include immunoglobulins, complement ...
(Date:7/11/2014)... DIEGO , July 11, 2014 Neurelis, ... Corp. ("Biotie") to end the option held by Biotie ... commence further development of NRL-1 (intranasal diazepam) for pediatric ... Over the past year, Biotie has advanced ... in preparation for the pivotal clinical work required for ...
(Date:7/10/2014)... -- The U.S. Department of Health and Human Services (HHS) ... Case Medical Center Seidman Cancer Center totaling $4.7 million ... care for patients with complex cancer. ... unique model developed at UH to enhance care for ... demonstrated need for high health care utilization.  ...
Breaking Medicine Technology:Immunoprotein Diagnostic Testing Market - Forecasts to 2019: Expected to grow at the highest CAGR of 6% and is expected to be valued at USD 4,943.0 million 2Neurelis Regains Rights to Intranasal Diazepam Program 2Neurelis Regains Rights to Intranasal Diazepam Program 3University Hospitals Case Medical Center Awarded $4.7 Million Grant from U.S. Department of Health and Human Services 2University Hospitals Case Medical Center Awarded $4.7 Million Grant from U.S. Department of Health and Human Services 3University Hospitals Case Medical Center Awarded $4.7 Million Grant from U.S. Department of Health and Human Services 4
... Calif., Oct. 27 Patient Safety Technologies, Inc. (the ... Dreyer as Vice President and Chief Financial Officer.  Mr. ... reporting requirements for the Company and its wholly-owned operating ... role in various strategic initiatives and operational improvements. ...
... in collaboration with the Philadelphia Eagles, today announced that ... Students Run Philly Style, Twilight Wish Foundation and The ... company,s ongoing commitment to supporting local organizations in the ... being awarded these grants in recognition of going above ...
Cached Medicine Technology:Patient Safety Technologies Appoints New Chief Financial Officer 2Teva Pharmaceuticals and the Philadelphia Eagles Award Four Grants to Greater Philadelphia Area Service Organizations 2Teva Pharmaceuticals and the Philadelphia Eagles Award Four Grants to Greater Philadelphia Area Service Organizations 3Teva Pharmaceuticals and the Philadelphia Eagles Award Four Grants to Greater Philadelphia Area Service Organizations 4Teva Pharmaceuticals and the Philadelphia Eagles Award Four Grants to Greater Philadelphia Area Service Organizations 5
(Date:7/11/2014)... July 11, 2014 Recently, Fadhits.com, the distinguished ... of kids prom dresses . To bring more benefits ... has also launched a special offer for these brand new ... 2014. , The company’s sales manager says gladly, “We are ... special offer is to acknowledge all new and old customers ...
(Date:7/11/2014)... prescribed exercise as medicine, according to a QUT ... is essential to reducing the risk of death ... QUT,s Institute of Health and Biomedical Innovation, said ... and mental health, health professionals should be prescribing ... Anderson and QUT,s Dr Charlotte Seib co-authored a ...
(Date:7/11/2014)... that people who have grown up on a farm ... urban counterparts to develop the most common inflammatory bowel ... have recently been published in the European Journal ... we can now see that not only allergic diseases, ... on the environment we are exposed to early in ...
(Date:7/11/2014)... Emily Johnson, owner of the Portland Fit Body Boot ... camp has held two charity workout events and is about ... from 7:15 - 8:30 at Col Summers City Park, SE 20th ... session raised $510 for Medical Teams International. Their second workout event ... Dream. On July 26th, Johnson and Portland Fit Body Boot ...
(Date:7/11/2014)... Recently, iFitDress.com, a leading online supplier of wedding ... new collection of evening dresses for 2014. ... all these beautiful items are provided with big discounts, ... offer is July 22. , According to the ... to customer satisfaction. On the company’s website, sincere customer ...
Breaking Medicine News(10 mins):Health News:Promotion for Kids Prom Dresses Now Provided at Fadhits.com 2Health News:Exercise is the best medicine: QUT study 2Health News:Growing up on a livestock farm halves the risk of inflammatory bowel diseases 2Health News:Portland Fit Body Boot Camp Invites Public to Fitness Boot Camp Session Benefiting Children’s Cancer Association 2Health News:Portland Fit Body Boot Camp Invites Public to Fitness Boot Camp Session Benefiting Children’s Cancer Association 3Health News:Worldwide Chic Ladies Can Buy Cheap Evening Dresses at iFitDress.com 2
... , MONDAY, July 25 (HealthDay News) -- As many ... this fall, the American Lung Association urged parents to prepare ... help ease their transition back to the classroom. "While ... necessities, it is even more essential for parents of students ...
... -- People who resume smoking after hospitalization for a heart ... for good, a new Italian study confirms. The ... times more likely to die than those who stop -- ... support long-term ,smoking-cessation efforts after discharge, the researchers said. ...
... special treatment. But when a woman with a ... a medical issue becomes pregnant, she needs highly specialized ... Hospital of Rhode Island has created New England,s only ... high-risk pregnancies and their developing fetuses. A collaboration of ...
... a picture of many trees, young people will tend to say: ... likely we are to notice a single tree before seeing the ... the bigger picture is slower in older people. In a new ... researchers have found that these age-related changes are correlated with a ...
... , MONDAY, July 25 (HealthDay News) -- Many doctors ... women at average and high risk for breast and ovarian ... of compliance could result in women missing out on treatments ... researchers pointed out in a report published in the July ...
... , FRIDAY, July 22 (HealthDay News) -- If you have ... your health may be at risk. In a review ... is linked with many types of poorer health outcomes and ... surprises here," said study author Nancy Berkman, senior health policy ...
Cached Medicine News:Health News:Preparation Key When Kids With Asthma Go Back to School 2Health News:Smoking After Heart Attack Raises Risk of Dying 2Health News:Women & Infants introduces integrated program for high-risk pregnancy 2Health News:Women & Infants introduces integrated program for high-risk pregnancy 3Health News:Older people find it harder to see the wood for the trees 2Health News:Many Doctors Ignore Cancer Genetic Testing Guidelines 2Health News:Low 'Health Literacy' Hazardous to Your Health 2
... peripheral nerve stimulator from B. Braun Medical. ... nerve stimulator functionality for over 10 years. ... available, a unique, under-the-glove hand held remote ... Dig. It allows the anesthesia provider operating ...
... Control allows hands-free operation in nerve locator ... 5.0 mA) with SoloStim provides a wide ... control when close to nerve., ,Supported ... block products, including the clinically proven ProBloc™ ...
... your investment., ,The Centiva/5 Critical Care Ventilator ... demands of the critical care environment. The Centiva ... combining a compact size with high levels of ... space around the patients bed and allows you ...
... Mesh Elastic is a lightweight and large pore ... mesh is able to adapt to all movements ... honeycomb like structure with the large pores enables ... The mesh is ideal for incisional hernia repair ...
Medicine Products: