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:8/22/2017)... ... ... The Women’s Choice Award, a growing platform that gives a voice to ... Award. The identification by women of an effective new migraine relief product ... In a survey taken by the Women’s Choice Award organization, nine out of ten ...
(Date:8/22/2017)... ... August 22, 2017 , ... Western North Carolina’s only ... popular international aesthetics conference for medical professionals about the positive impact Juliet™ ... his growing practice. , Dr. George K. Ibrahim shared the results ...
(Date:8/22/2017)... ... ... six years, Lightning Labels has sent out a call for users of its custom label ... of their designs. Submissions this year were open from May 18 to July 1 and ... of the sixth annual Photo Contest, along with the prizes they've received:, ...
(Date:8/22/2017)... ... 2017 , ... Nurses at Apple Rehab Watch Hill , a nursing ... and certification in Closed Pulse Irrigation™ (CPI) for wound care. This qualifies ... Centers for Medicare and Medicaid Services, to have a CPI machine that will provide ...
(Date:8/22/2017)... (PRWEB) , ... August 22, 2017 , ... “To Walk ... radioman on a B17 bomber named Edward Koontz. “To Walk Away” is the creation ... Scranton, who has published over two hundred manuscripts in chemistry and religion, as well ...
Breaking Medicine News(10 mins):
(Date:8/8/2017)... Ltd. (NASDAQ/TASE: BLRX), a clinical-stage biopharmaceutical company focused on ... the second quarter ended June 30, 2017. ... to date: Continued ... lead project, BL-8040: Announced plans to ... stem cell mobilization treatment for autologous bone-marrow transplantation in ...
(Date:8/7/2017)... Ind. , Aug. 7, 2017 Zimmer Biomet ... musculoskeletal healthcare, today announced that its Board of Directors has ... for the third quarter of 2017. ... be paid on or about October 27, 2017 to stockholders ... 22, 2017.  Future declarations of dividends are subject to approval ...
(Date:8/7/2017)... International plc (NASDAQ: ENDP ) today announced that ... U.S. mesh product liability claims and that it is ... claims at reasonable values. Under the agreements, Endo will ... 2017 and continuing through the fourth quarter of 2019. ... Company intends to increase its mesh product liability accrual ...
Breaking Medicine Technology: