Navigation Links
Cyberonics Provides Business Update on Depression Clinical Trial
Date:1/7/2009

HOUSTON, Jan. 7 /PRNewswire-FirstCall/ -- Cyberonics, Inc. (Nasdaq: CYBX) today announced that it has made a proposal to the U.S. Food and Drug Administration ("FDA") to amend the protocol of its post-market dosing study (D-21) in depression patients treated with VNS TherapyTM.

Based on a reassessment of the study power and size following the FDA's approval of an amendment to the data analysis originally specified in the study protocol, the company proposes to reduce the number of study subjects from 460 to 330, while still maintaining appropriate study power. The company expects to meet this revised enrollment level within one to two months and will thereafter suspend further patient enrollment pending FDA's decision on its proposed amendment, which was submitted in November 2008. The company expects to complete the follow-up on all patients enrolled in the study. At this time, the company does not know when to expect a decision from the FDA.

About Cyberonics, Inc. and VNS TherapyTM

Cyberonics, Inc. (NASDAQ: CYBX) is a medical technology company with core expertise in neuromodulation. The company developed and markets the Vagus Nerve Stimulation (VNS) Therapy(TM) System, which is FDA-approved for the treatments of refractory epilepsy and treatment-resistant depression. The VNS Therapy System uses a surgically implanted medical device that delivers pulsed electrical signals to the vagus nerve. Cyberonics markets the VNS Therapy System in selected markets worldwide.

Additional information on Cyberonics, Inc. and VNS Therapy(TM) is available at www.cyberonics.com and www.vnstherapy.com'/>"/>

SOURCE Cyberonics, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3

Related biology technology :

1. Cyberonics Provides Update on Business Operations Following Hurricane Ike
2. Cyberonics Reports Strong Revenue Growth and Profitability in Fiscal 2008 Fourth Quarter
3. Vasogen Provides Corporate Update
4. Neurobiological Technologies Partner, Celtic Pharma, Provides Update on XERECEPT(R) Clinical Program and Planned Sale in 2009
5. Cornerstone Therapeutics Provides Update on Integration Activities and Issues 2008 Revenue Guidance
6. GeneNews provides Centocor access to its osteoarthritis program
7. ATS Medical Provides Update on US Commercialization of Its ATS 3f Aortic Bioprosthesis
8. YM BIOSCIENCES PROVIDES EU REGULATORY UPDATE
9. New Report Provides Expert Analysis of Recent Advances and Setbacks in Parkinsons Disease Drug Development
10. ZhenSpa.com provides Spa Enthusiasts Affordable Alternatives for Expensive Spa Treatments
11. New Radiation-Blocking Medical Garments Introduced at RSNA Meeting in Chicago : Demron-M Technology Provides Total Protection in a Lightweight, Durable, Flexible Fabric
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/3/2015)... , Aug. 3, 2015   Intrexon Corporation ... release first half and second quarter 2015 financial results ... , 2015.  The Company will host a conference call ... provide a general business update. The conference ... and 1-412-902-4262 (International), and asking to join the "Intrexon ...
(Date:7/31/2015)... LAS VEGAS , July 31, 2015 /PRNewswire/ ... pharmacists seek resources that help them drive positive ... as a vital source of patient care in ... Pharmacy,s annual tradeshow and conference, AmerisourceBergen announced ... strengthen its Pharmacy Services Administration Organization and help ...
(Date:7/30/2015)... MN (PRWEB) , ... July 31, 2015 , ... Ralco ... Enrichment Center at the Lyon County Fair to be held August 5-9 in Marshall. ... about where their meals come from and how agriculture impacts their daily lives. This ...
(Date:7/30/2015)... Texas (PRWEB) , ... July 30, 2015 , ... The ... and in-depth study on the current state of the global Propanol market with a ... Sinopec, CNPC, BASF, Eastman, Dow, Carboclor, Mitsui Chemicals, Oxea, ISU Chemical, Sanofi, Royal Dutch ...
Breaking Biology Technology:Intrexon to Announce First Half and Second Quarter 2015 Financial Results and Host Conference Call on August 10th 2AmerisourceBergen Unveils Suite of Enhanced Capabilities for Independent Pharmacies at ThoughtSpot 2015 2AmerisourceBergen Unveils Suite of Enhanced Capabilities for Independent Pharmacies at ThoughtSpot 2015 3Ralco Announces Primary Sponsorship of Ralco Enrichment Center at Lyon County Fair 2Global Propanol Market Technical Data and Manufacturing Analysis 2020 2Global Propanol Market Technical Data and Manufacturing Analysis 2020 3
... Yondelis(R) sales network across Western Europe, BRACKNELL, ... services agreement with PharmaMar, a subsidiary of Zeltia ... sales team in Western,Europe to promote Yondelis(R), PharmaMar,s ... marketing authorization, will be,responsible for marketing the drug., ...
... new data,demonstrating that the investigational drug lacosamide, with ... therapy,significantly reduced the frequency of seizures and was ... up,to 5.5 years. The results of the two ... today at the 61st annual meeting of the ...
... LIFE. "Fertility & Diet" (p. 54). The latest chapter,of ... research on,how foods impact the odds of getting pregnant. ... M.D., and Patrick,J. Skerrett, authors of the new book ... weight control play in conception and weigh in on,their ...
Cached Biology Technology:Innovex to Promote PharmaMar's Yondelis(R) Cancer Treatment 2Innovex to Promote PharmaMar's Yondelis(R) Cancer Treatment 3UCB Announces New Data Showing Investigational Drug Lacosamide Significantly Reduced Seizures in Refractory Epilepsy Patients 2UCB Announces New Data Showing Investigational Drug Lacosamide Significantly Reduced Seizures in Refractory Epilepsy Patients 3UCB Announces New Data Showing Investigational Drug Lacosamide Significantly Reduced Seizures in Refractory Epilepsy Patients 4NEWSWEEK: Media Lead Sheet/December 10, 2007 Issue (on newsstands Monday, December 3). 2NEWSWEEK: Media Lead Sheet/December 10, 2007 Issue (on newsstands Monday, December 3). 3NEWSWEEK: Media Lead Sheet/December 10, 2007 Issue (on newsstands Monday, December 3). 4NEWSWEEK: Media Lead Sheet/December 10, 2007 Issue (on newsstands Monday, December 3). 5
(Date:7/31/2015)... China , 31 de julio de 2015 /PRNewswire/ ... Genómica (ICG-10,  www.icg-10.org ) del 22 al 25 de ... . La conferencia celebra su décimo aniversario ... ha convertido en una de las reuniones anuales más ... y es una de las conferencias científicas más dinámicas, ...
(Date:7/31/2015)... -- Die 10. internationale Konferenz zu Genomik (ICG-10, ... findet vom 22. bis 25. Oktober 2015 in ... Die Konferenz feiert in diesem Jahr ... die ICG weltweit zu einem der einflussreichsten jährlichen ... der dynamischsten, enthusiastischsten und angenehmsten wissenschaftlichen Zusammentreffen. ...
(Date:7/27/2015)... 27, 2015  Synaptics Inc. (NASDAQ: SYNA ... today announced that Huawei has selected the Synaptics ... its stylish smartwatch. Huawei chose the state-of-the-art ClearPad ... power and highly responsive human interface qualities such ... also required a classic round watch face and ...
Breaking Biology News(10 mins):La 10ª Conferencia Internacional sobre Genómica (ICG-10) comienza en octubre 2La 10ª Conferencia Internacional sobre Genómica (ICG-10) comienza en octubre 3Die 10. internationale Konferenz zu Genomik (ICG-10) beginnt im Oktober 2Die 10. internationale Konferenz zu Genomik (ICG-10) beginnt im Oktober 3Synaptics Touchscreen Solution Powers New Huawei Watch 2Synaptics Touchscreen Solution Powers New Huawei Watch 3
... research into the Earth,s paleoclimate history by NASA,s Goddard ... the potential for rapid climate changes this century, including ... is not abated. By looking at how the ... insight into a fundamental question raised by ongoing human-caused ...
... MADISON -- Shifting a fraction of truck-borne freight onto trains ... Midwest, according to researchers at the University of WisconsinMadison. ... to Erica Bickford, a graduate student in UWMadison,s Nelson Institute ... go about 150 miles on a gallon of diesel fuel. ...
... Medical School have made an important discovery about the ... on our understanding of how proteins regulate appetite control ... Zammit, Head of Metabolic and Vascular Health at Warwick ... palmitoyltransferase 1A, (CPT1) has a switch which is thrown ...
Cached Biology News:Paleoclimate record points toward potential rapid climate changes 2Paleoclimate record points toward potential rapid climate changes 3Paleoclimate record points toward potential rapid climate changes 4For Midwesterners, more boxcars mean cleaner air 2
Biotin anti-human CD164...
Can be used for the quantitative recovery of small amounts of nucleic acids within dilute solutions. 5mg/ml...
EDTA, 0.5 M solution, 100 ml. Ethylene diaminetetraacetic acid.Sterile, nuclease-free. Category: Nucleotides & Enzymes & Biochemicals, Ultrapure Biochemicals ....
Recombinant Mouse TGF-beta RII/(human) Fc Chimera, CF...
Biology Products: