Caisson Interventional Completes First in Human Implants of Its Transvascular Mitral Valve Replacement
(Thomson Reuters ONE) -
NYU Langone Medical Center Implants First Patients with Groundbreaking New
Investigational Device
MAPLE GROVE, Minn., Sept. 16, 2016 (GLOBE NEWSWIRE) -- Caisson Interventional,
LLC ("Caisson" or the "Company") announces the first successful human implants
of its fully percutaneous, transvascular mitral valve implant designed as a
functional replacement in a diseased, damaged, or malfunctioning mitral valve.
Mathew R. Williams, M.D. and his team from the Heart Valve Center at NYU Langone
successfully implanted three patients with the Caisson Transcatheter Mitral
Valve System. These are the first patients enrolled in the PRELUDE Study
(Percutaneous Mitral Valve Replacement EvaLuation Utilizing IDE Early
Feasibility Study). The study is designed to provide initial data on the safety
and performance of the Caisson TMVR System. The U.S. Food and Drug
Administration (FDA) approved the Investigational Device Exemption (IDE) for the
PRELUDE study under the Early Feasibility Study program for up to 20 patients in
5 centers.
The Company also reports one patient was successfully implanted in July under
the direction of Eric Cohen, M.D. and Gideon Cohen, M.D. at the Schulich Heart
Centre at Sunnybrook Health Sciences Centre (Toronto) under the Health Canada
Special Access Programme.
The physicians involved stated the patients responded very well to the implant
with excellent valve function. They also commented the delivery system
performed as designed and facilitated proper placement of the implant with
precise control at each step of the procedure.
Dr. Williams, NYU Langone's chief of Adult Cardiac Surgery, and director of
Interventional Cardiology and Structural Heart commented, "NYU Langone is a
recognized world leader in cardiac care and we are dedicated to bringing the
most advanced minimally-invasive technologies to our patients. We are proud to
be the first medical center in the world to successfully implant three high risk
patients with Caisson's cutting-edge new technology to treat their severe
symptomatic mitral regurgitation. Thanks to NYU Langone's focus on innovation
in the field, and the FDA's dedication to the Early Feasibility Study (EFS)
Program, we have the opportunity to be involved with this first-in-class
technology at the earliest stage of clinical evaluation."
The Caisson implant consists of two components; an Anchor constructed of a
Nitinol frame and a pericardial tissue Valve attached to a Nitinol frame. The
implant is fully repositionable and retrievable and only released after the
function of the implant is fully assessed. The entire procedure is completed
through a single percutaneous femoral venous access utilizing a trans-septal
approach to the native mitral valve.
Caisson Interventional CEO C.J. Schweich Jr., M.D. said, "We are thankful to the
NYU Langone and Sunnybrook teams for their dedication to outstanding patient
care and participation in this groundbreaking clinical experience. These
initial implants mark a significant milestone for Caisson's technology in
understanding its potential to benefit a significant number of patients with
severe mitral regurgitation and limited therapeutic options."
About the company: Caisson Interventional, LLC. is a privately held clinical-
stage medical device company located in the Minneapolis area focused on the
design, development, and clinical evaluation of a novel percutaneous mitral
valve replacement system. The Caisson Mitral Valve Replacement System is
approved for investigational use in the United States and therefore limited by
Federal (or United States) law to investigational use only.
CONTACT:
Caisson Interventional, LLC
C.J. Schweich, Jr., M.D.
Chief Executive Officer
763.220.4110
cjschweich(at)caissonint.com
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Caisson Interventional via GlobeNewswire
Datum: 16.09.2016 - 14:18 Uhr
Sprache: Deutsch
News-ID 495243
Anzahl Zeichen: 4601
contact information:
Town:
Maple Grove
Kategorie:
Business News
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"Caisson Interventional Completes First in Human Implants of Its Transvascular Mitral Valve Replacement"
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