Navigation Links
Emphasys Medical Announces PMA Submission for Bronchial Valve Therapy
Date:10/1/2007

- Data from Positive VENT Trial Presented at ERS 17th Annual Congress -

REDWOOD CITY, Calif., Oct. 1 /PRNewswire/ -- Emphasys Medical Inc. today announced the submission of a pre-market approval (PMA) application to the U.S. Food and Drug Administration (FDA) requesting regulatory approval to market the Emphasys endobronchial valve, the Zephyr(R) EBV, in the United States. The Zephyr EBV is a minimally invasive and potentially reversible treatment option intended to help patients with emphysema breathe easier.

The PMA submission was based on data from the company's pivotal trial, the Endobronchial Valve for Emphysema PalliatioN Trial (VENT). VENT was a randomized, multi-center trial enrolling 321 patients with severe heterogeneous emphysema. This trial was designed based on input from a panel of expert clinicians convened by the FDA in February 2003 to help establish the appropriate clinical endpoints for medical device treatments of emphysema. The VENT study's primary efficacy endpoints were improvement in lung function as measured by forced expiratory volume in one second (change in FEV1) and exercise tolerance as measured by a six minute walk test (6MWT) both at six months. The primary safety endpoint was a composite of major complications at six months.

Data from VENT was recently presented at the European Respiratory Society (ERS) 17th Annual Congress. VENT met both its primary efficacy endpoints showing statistically significant improvements in lung function (p=0.0047) and exercise tolerance (p=0.0073). VENT also showed the Zephyr EBV to have a favorable safety profile in terms of major complications between the treatment and control groups. At the six-month follow-up, protocol-defined major complications occurred in 5.9% of treated patients compared to 1.0% of control patients. The difference did not reach statistical significance. Investigators also reported on select patient subsets. In patients defined as having physiologically isolated target lung zones and correct Zephyr EBV placement, FEV1 was increased by 21% (p<0.0001).

About the Emphasys Zephyr(R) EBV

The Zephyr EBV is a small one-way silicone valve that is inserted into airways to prevent air from entering the diseased portion of the lung during inhalation, while allowing air and fluids to escape during exhalation. The Zephyr EBV is intended to mitigate the effects of emphysema by isolating the targeted diseased portion of the lung, causing a reduction in volume of the diseased region and allowing the healthier portions of the lung to function more normally. The Zephyr EBV has also been used for the treatment of lung air leaks in limited circumstances under a compassionate use protocol approved by the FDA on a case-by-case basis. Procedures using the Zephyr EBV are potentially reversible, if necessary, and the valves can be removed with standard bronchoscopic tools.

The Zephyr EBV system is approved for commercial use in Europe, Australia, Hong Kong and Singapore. The Zephyr EBV system is limited to investigational use in the United States.

About Emphasys Medical

Emphasys Medical is a medical technology company focused on developing and commercializing therapeutic devices for the treatment of patients with emphysema and other debilitating breathing disorders.

This press release contains statements that are forward-looking in nature. Statements preceded by the words believe, expect, anticipate, plan, intend, continue, estimate, may, will, and similar expressions are forward-looking statements. Forward-looking statements are based on the Company's beliefs and assumptions based on information available at the time the assumption was made. Forward-looking statements relate to, among other things, strategies, development timelines, regulatory developments and the timing and likelihood of commercialization of our products candidates, relating to the Company. By its nature, such forward-looking information is subject to various risks and uncertainties which could cause the Company's actual results and experience to differ materially from the anticipated results or other expectations expressed. Readers are cautioned not to place undue reliance on this forward- looking information, which is given as of the date it is expressed in this document, and the Company undertakes no obligation to update publicly or revise any forward looking information, whether as a result of new information, future events or otherwise.


'/>"/>
SOURCE Emphasys Medical Inc.
Copyright©2007 PR Newswire.
All rights reserved

Related medicine news :

1. Check if your “Favourite medical web-site” is indulging in Quackey
2. Teens turning to Internet for medical queries
3. Robots craft medical history
4. NBE to conduct test for medical students from abroad
5. Air pollution combined with greater medical needs
6. Indian Nationals with Foreign Medical Degrees can now practice in India
7. Children! Protecting them from medical mistakes
8. More information sought by patients on medical errors
9. SARS necessitates medical masks
10. Meditation Works Medically
11. Sleep Disorders Could Indicate Other Medical Problems
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/28/2017)... ... April 28, 2017 , ... Intellitec Solutions announced ... Foundation implement a Microsoft Dynamics GP solution that integrates to their PointClickCare EHR ... specializes in long-term care, Brooke Grove now has the capability to achieve its ...
(Date:4/28/2017)... ... April 28, 2017 , ... Semrock’s highly popular SearchLight Spectra ... modeling resource for fluorescence microscopists and optical system designers, enabling The Right Solution, ... spanning the globe, SearchLight has become a tremendously popular tool for the fluorescence ...
(Date:4/27/2017)... (PRWEB) , ... April 27, 2017 , ... Healthcare companies ... But they will rapidly reject an outdated healthcare executive resume. , “If you’re a ... at your executive resume and wondering if it’s as ready as you are for ...
(Date:4/27/2017)... Reston, VA (PRWEB) , ... April 27, 2017 ... ... mobile application containerization, today announced an exhibitor sponsorship at MobileIron Live! 2017 ... leaders, and new technologies for an immersive, educational approach to helping organizations maximize ...
(Date:4/27/2017)... ... April 27, 2017 , ... Plastic Surgery Associates is excited to announce ... present at the upcoming Aesthetic Meeting. Held in San Diego, at the San Diego ... Canales will lend their expertise to the Premier Global Hot Topics session, speaking on ...
Breaking Medicine News(10 mins):
(Date:4/20/2017)... 20, 2017  CVS Pharmacy, the retail division ... new store design to enhance the retail customer ... health-focused products and expanded beauty selections paired with ... discover new offerings. Together with its innovative digital ... the customer experience at CVS Pharmacy.  ...
(Date:4/20/2017)... Eyevensys, a private biotechnology company ... expression technology that enables the safe, local, sustained production ... wide range of ophthalmic diseases, announces it has received ... Agency (MHRA) to advance its technology into clinical development. ... The EyeCET ...
(Date:4/19/2017)... , April 19, 2017 Cardiology devices segment is ... period The Cardiology Devices segment is likely to ... 15 Mn in 2018 over 2017. By the end of ... valuation close to US$ 700 Mn, expanding at a CAGR ... dominated the Asia Pacific reprocessed medical ...
Breaking Medicine Technology: