Navigation Links
Synapse Biomedical Receives FDA Approval of NeuRx Diaphragm Pacing System (DPS)(TM) For Spinal Cord Injury Breathing Applications
Date:6/18/2008

NeuRx DPS(TM) Allows Patients To Breathe Without Ventilator

Clinical Trials Also Underway For ALS Patients

CLEVELAND, June 18 /PRNewswire/ -- Synapse Biomedical Inc. (http://www.synapsebiomedical.com) announced today it has received approval from the U.S. Food and Drug Administration (FDA) for its NeuRx DPS(TM) for ventilator-dependent Spinal Cord Injury (SCI) patients who lack voluntary control of their diaphragms. With the FDA's approval, SCI patients and their caregivers throughout the U.S. can now access this technology that was previously only available to clinical trial participants.

(Photo: http://www.newscom.com/cgi-bin/prnh/20080618/CLW020 )

(Fact sheets, patient testimonial, product video and images: http://www.synapsebiomedical.com/news/media)

The device implanted through minimally invasive laparoscopic surgery, provides electrical stimulation to muscle and nerves that run through the diaphragm. When stimulated by the NeuRx DPS(TM), the diaphragm contracts, mimicking natural breathing, and allows air to fill the upper and lower parts of the lungs rather than forcing air in with a mechanical ventilator.

The NeuRx DPS(TM) received the CE Mark (CE Registration #518356) on November 20, 2007 and is approved for treating patients with diaphragm dysfunction in the European Union. Seven successful implants have occurred at leading European hospitals including: Charite - Univeritatsmedizin (Berlin); Groupe Hospitalier Pitie-Salpetrier (Paris) and Institut GUTTMANN - Hospital De Neuro Rehabilitacio (Barcelona) since that date.

The FDA decision was completed after clinical testing, which began with clinical trials starting in 2000 under Investigational Device Exemption #G920162.

Th
'/>"/>

SOURCE Synapse Biomedical Inc.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6

Related medicine technology :

1. Boston University Biomedical Engineers Find Chink in Bacterias Armor
2. Nobel Prize Awarded to Foundation for Biomedical Research Board Member
3. Saladax Biomedicals 5-FU Personalized Chemotherapy Management (PCM(R)) Assay CE Marked for Distribution in the EU
4. Reclast(R) Receives US FDA Approval as First and Only Once-Yearly Treatment for Women With Postmenopausal Osteoporosis
5. Indevus Receives Approvable Letter From FDA for VALSTAR(R) for Bladder Cancer Therapy
6. Auxilium Pharmaceuticals, Inc. Receives Clearance to Resume Clinical Trials for XIAFLEX(TM)
7. Abbott Receives Supplemental FDA Approval for its Best-in-Class in Sensitivity RealTime HIV-1 Viral Load Test
8. GlaxoSmithKline Receives New HHS Order for H5N1 Bulk Antigen. First North American Clinical Trials with GSKs Candidate Pre-pandemic Flu Vaccine to Start.
9. CryoCor Receives FDA Approval for Right Atrial Flutter
10. Ranbaxy Receives Approval to Manufacture and Market Hydrocodone Bitartrate and Acetaminophen Tablets USP
11. Dimericine(R) Receives FDA Fast Track Designation for Treatment Of Photosensitivity in XP Patients
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/23/2015)... MYERS, Fla. , Jan. 23, 2015  Today the ... of Novartis, Bexsero® for the prevention of serogroup ... 25. Bexsero and Pfizer,s vaccine Trumenba®, which received FDA ... helping prevent this devastating disease. "I ...
(Date:1/23/2015)...  A new analysis of Centers for Medicare and Medicaid ... that 81 percent of seniors chose lower-cost preferred pharmacy ... certain pharmacies. The findings were released by Drug ... the foundation of Medicare Part D," said Pharmaceutical Care ...
(Date:1/23/2015)... Feffer LLP ( www.hfesq.com ) is investigating potential claims ... or the "Company") (NASDAQ: ADXS ), concerning ... shareholders. On January 21, 2015, an article ... had misrepresented the clinical data for its ADXS-HPV drug ...
Breaking Medicine Technology:The National Meningitis Association (NMA) Applauds FDA Approval of Second Vaccine To Protect Against Serogroup B Meningococcal Disease 2New Analysis: 81 Percent of Medicare Part D Seniors Choose "Preferred Pharmacy" Plans in 2015 2Harwood Feffer LLP Announces Investigation of Advaxis, Inc. 2
... 8 CVS/pharmacy was recently honored by two transportation ... operations of its Logistics Department. The Company received ... the "Under 25 Million Miles" category. In addition, ... a driver based in CVS/pharmacy,s Knoxville, TN distribution center ...
... Advanced Health Media, LLC (AHM) has acquired Ephikacy, LLC, ... for the pharmaceutical and life sciences industries. , Advanced ... management, supplying automation and compliance management systems to more ... more than 200 brands. The addition of Ephikacy,s ...
Cached Medicine Technology:CVS/pharmacy's Transportation Operations Receives Two National Safety Awards 2Advanced Health Media Announces Acquisition of Ephikacy, LLC 2Advanced Health Media Announces Acquisition of Ephikacy, LLC 3
(Date:1/22/2015)... January 22, 2015 Liberty University has received ... program from the Council for Accreditation of Counseling ... of Liberty’s Center for Counseling & Family Studies , ... of the university’s new School of Behavioral Sciences. Prior to ...
(Date:1/22/2015)... 2015 Woodloch Pines, an all-inclusive family ... by TripAdvisor as the number one best large hotel for ... the world for their annual Travelers’ Choice Awards. , ... The website is home to millions of unbiased and honest ...
(Date:1/22/2015)... January 23, 2015 VogueQueen is a seasoned ... prices and many designers are thrilled to have it lead ... announces its new collection of prom dresses for the global ... drive the strategic vision and he focuses on continuing the ...
(Date:1/22/2015)... January 22, 2015 Blue Cross and Blue ... who exemplify what it means to “Live Fearless.” ... people to share their stories about how they or someone ... inspired others by living in the moment. By telling these ...
(Date:1/22/2015)... Florida (PRWEB) January 22, 2015 Juvent ... today at the 2015 PGA Merchandise Show to bestow ... and incredible female amateur golfer, Arlene McKitrick. The award ... female amateur golf tournament win. She won her first ...
Breaking Medicine News(10 mins):Health News:Liberty University's Resident Master’s Counseling Program Receives CACREP Accreditation 2Health News:TripAdvisor Names Woodloch Pines Best Hotel for Families in America 2Health News:TripAdvisor Names Woodloch Pines Best Hotel for Families in America 3Health News:VogueQueen Unveils New Designs of Prom Dresses for 2015 2Health News:Blue Cross and Blue Shield of Minnesota to Showcase “Faces of Fearless” 2Health News:All-Time Leading Female Amateur Golfer Arlene McKitrick Receives Juvent Sports Achievement Award at 2015 PGA Show 2Health News:All-Time Leading Female Amateur Golfer Arlene McKitrick Receives Juvent Sports Achievement Award at 2015 PGA Show 3
... patients should be classified as soon as possible, researchers ... should aggressively evaluate indeterminate breast lesions found in women ... of a new study suggest. , An indeterminate breast ... malignant or benign. High-risk women include those who have ...
... risk of developing high blood pressure, diabetes , MONDAY, ... risk of developing diabetes and high blood pressure but don,t ... heart disease, a new study reports. , "Diabetes and hypertension ... across the globe," Dr. Henry R. Black, president of the ...
... breast lesions found on breast magnetic resonance imaging (MRI). ... women with a high risk of breast cancer) should ... to a study to be presented at the ARRS ... lesions that cannot be definitively classified as suspicious for ...
... (May 3, 2010) While timely care can reduce stress ... expediency should not compromise other factors important to care, such ... findings published in the April issue of the Journal ... receive a breast cancer diagnosis and one in eight ...
... disease and diabetes, now appears to be associated with another ... testosterone levels. Results of a study published online ... conducted by University at Buffalo endocrinologists, showed that 40 percent ... study had lower-than-normal testosterone readings. The percentage rose to ...
... great risk of developing obesity. In the current issue ... his colleagues from Witten/Herdecke University describe possible ways to ... 107(15): 268-75). , There are many reasons that ... be the disability itself, for example, if this includes ...
Cached Medicine News:Health News:Aggressive Action Urged When Evaluating Breast Lesions 2Health News:'Healthy' Pre-Diabetics Still Face Heart Disease Threat 2Health News:Study evaluates importance of timeliness of care in breast cancer diagnosis and treatment 2Health News:Study evaluates importance of timeliness of care in breast cancer diagnosis and treatment 3Health News:Male obesity linked to low testosterone levels, study shows 2Health News:Male obesity linked to low testosterone levels, study shows 3
Narrow smooth jaws. Serrated handle with polished finish....
Slender 4.5 mm long rounded platform. Serrated handle with polished finish....
Oval solid 24 mm wide lower plate. Open upper plate with inside dimensions 12 mm x 20 mm. Serrated handle with locking thumb screw and polished finish....
Round solid 15 mm wide lower plate. Open upper plate with inside diameter 12 mm. Serrated handle with locking thumb screw and polished finish....
Medicine Products: