Dear Wiz,
Thank you for your question on the VENT procedure for COPD. This is a
procedure that involves using a bronchial valve developed by Emphasys
being run by Dr. Armin Ernst, MD, director of the Center for
Interventional Pulmonary at Beth Israel Deaconess Medical Center
(Boston, Massachusetts). The Clinical Trial of this device involves
multiple centers in the US, including the Medical University of South
Carolina (MUSC), where Dr. Charles Strange is based. Here is an
article about the VENT procedure in which Dr. Strange is quoted:
http://www.atvcapital.com/news.php?id=150
"Hasenzahl says that she refused to be defeated by the disease, and
via Internet research, learned of the Emphasys pivotal trial for the
EBV device, with one of the sites being the nearby Medical University
of South Carolina (Charleston). She immediately contacted investigator
Charles Strange, MD, a specialist in pulmonary and critical care
medicine. After acceptance for enrollment, Hasenzahl was Strange?s
sixth implantee with the device on May 18, and Strange is set to
perform another procedure this week."
In the same article, the VENT trial is described:
"...the Endobronchial Valve (EBV) made by Emphasys (Redwood City,
California) and being among the first to receive the device in the
early stages of the company?s first clinical trial, titled VENT, for
Endobronchial Valve for Emphysema Palliation Trial."
"John McCutcheon, president and CEO of Emphasys, describes the small
device as having ?a very simple design ? it?s a one-way valve made of
a nitinol retainer and a silicon seal and silicon valve in the middle.
It goes into the airways, retrograde to inhalation. On inhale, it
closes and blocks air from going into the most diseased areas [of the
lung]; on exhale, air is allowed to escape from these areas.?
Plans call for VENT enrollment of 270 patients across the U.S. and
Europe and will consist of two arms: The control arm will receive
standard optimal medical management, and the treatment arm will
receive the EBV procedure. Patients in both arms will undergo
pulmonary rehabilitation prior to randomization."
Here is a website for the company that developed the EBV device (Emphasys):
http://www.emphasysmedical.com/wt/home
Here is a link to the company's website describing the clinical trial
of the EBV device (VENT):
http://www.emphasysmedical.com/wt/emp/clinical_trials
Here is an overview of the idea behind the device:
http://www.emphasysmedical.com/wt/emp/clinicians
Here is a more in depth description of the procedure by which the
device is implanted, along with a diagram:
http://www.emphasysmedical.com/wt/emp/procedural_overview
-------------
Here is another news article about the clinical trial:
http://www.wibw.com/news/features/2/1354707.html
Here's a quote:
"It aims to see if implanting a special device, the size of a pencil
eraser, can help patients like Donna catch the breath they've lost as
COPD has literally dissolved the connective tissue in their lung.
'It would be like a balloon just overinflating - the lung turns into a
balloon that overinflates,' Dr. Leeds describes the problem. 'If you
try to blow more air into it, it's very difficult.'
Doctors use a bronchoscope, sort of like a small telescope, to place
the device into the affected lung passage. The device blocks air from
going into that overinflated area of the lung, while still allowing
gasses to escape. By blocking air from getting in, the volume of the
lung will shrink.
Dr. Leeds says 'that will allow the good lung underneath it to expand
and take over the space.'
The procedure is done under mild sedation, with no general anesthesia
and no scalpel required. Because it's a trial, Dr. Leeds and the
entire staff he's working with at Stormont-Vail, where he does the
procedure, underwent special training to take part."
This article goes on to describe the procedure, as well as inclusion
and exclusion criteria:
"Study Description: The VENT research study is being conducted to
assess the safety and efficacy of the Emphasys Endobronchial Valve
(EBV). Patients will be randomized to receive either standard optimal
medical management (with pulmonary rehabilitation) (control group) or
the Emphasys Endobronchial Valve and procedure (with pulmonary
rehabilitation) (treatment group).
Treatment: The Emphasys Endobronchial procedure is performed
bronchoscopically under routine anesthesia using the EBV implantable
device."
"Inclusions:
*Age: 40-75
*BMI<31.1 kg/mē (men) or, 32.3 kg/mē (women)
*FEV1 (must be less than 45% of predicted value)
*6MWT must be greater than or equal to 140 meters (you must be able to
walk at least 140 meters without stopping)
*No smoking for past 4 months prior to initial interview and
throughout the screening process
Exclusions include:
*FEV1 must be greater than 15% of predicted value
*Prior lung transplant, LVRS, lobectomy or other procedure requiring a
median sternotomy
*Pulmonary nodule requiring surgery
*History of recurrent infections requiring hospitalization (more than
1 hospitalization due to a respiratory infection within the last year)
*More than 4 tablespoons (60ml) per day of sputum production
*Heart attack or congestive heart failure within the last 6 months
*Exercise related syncope (fainting)
*Other life threatening disease or condition that compromises survival
during a 5 year period or interferes with follow-up assessments
*Enrollment in another clinical trial
*Unplanned significant weight loss
*Alpha-1 antitrypsin deficiency
Note: Patient must be willing and able to participate in a Pulmonary
Rehabilitation throughout the duration of study participation (both
in-home and therapist assisted sessions are required)."
-------------------
Here is an address and contact information for Dr. Strange:
Charles Strange, MD
Site Investigator
Associate Professor of Medicine
Division of Pulmonary and Critical Care Medicine
96 Jonathan Lucas Street
Charleston, SC 29425
E-Mail: strangec@musc.edu
Phone: 843-792-2153
Fax: 843-792-0732
Pulmonary & Critical Care Medicine, Allergy & Clinical Immunology
P.O. Box: 250630
Room #:812
Clinical Science Bldg. - 96 Jonathan Lucas St.
-----------------
I hope this information was useful. Please feel free to ask for clarification.
Best,
-welte-ga |
