Printer Friendly
The Free Library
14,506,802 articles and books
Member login
User name  
Password 
 
Join us Forgot password?

MedicalCV, Inc. to Amend 510(k) Submission of Its Automated Surgical Ablation System for Cardiac Tissue Ablation to Seek Soft Tissue Clearance.


Company Renames Such System the SOLAR[TM] System

INVER GROVE HEIGHTS Inver Grove Heights, city (1990 pop. 22,477), Dakota co., SE Minn. A suburb of St. Paul, its manufactures include motor-vehicle and aircraft parts, asphalt, feeds, consumer goods, building materials, paper products, and medical equipment. , Minn. -- MedicalCV, Inc. (OTCBB OTCBB

See OTC Bulletin Board (OTCBB).
:MCVI MCVI Michigan Cardiovascular Institute (Bay City, Michigan)
MCVI Miami Cardiac and Vascular Institute
), a cardiovascular surgery cardiovascular surgery Heart surgery An operation for repairing structural defects of the cardiovascular system Examples CABG, repair of congenital heart defects, varicose veins, aortic aneurysms, ventricular remodeling, transmyocardial  company, announced today that it has determined to amend its 510(k) submission for clearance of its SOLAR[TM] automated surgical ablation system. The Company will initially seek a soft tissue clearance. The SOLAR System, the latest innovative addition to the company's family of laser-based systems, is intended to enable precise delivery and consistent dosing of laser energy for ablating tissue by leveraging flexible, fiber-optic technology. The automated SOLAR System will complement the company's existing and already cleared cardiac tissue ablation platform, the ATRILAZE[TM] System, which is currently used in both open-heart and minimally invasive cardiac surgery minimally invasive cardiac surgery Interventional cardiology Any of a number of techniques–MIDCAB, off-pump coronary-artery bypass, minimally invasive valve surgery, port-access coronary surgery, and port-access valve surgery–increasingly being used to  procedures.

After discussions with the U.S. Food and Drug Administration and the Company's FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 counsel, the Company has determined to amend its application at this time to seek a soft tissue clearance for the SOLAR automated surgical ablation system. Upon such clearance, which is expected to be forthcoming, the Company plans to immediately commence marketing of the SOLAR System for soft tissue ablation. Commensurate with the launch of the SOLAR System, the Company will work with its Scientific Advisory Board to design and implement a protocol to collect clinical data to support a subsequent regulatory submission to obtain a specific clearance of the SOLAR System for cardiac tissue ablation. The Company also anticipates the development of a clinical protocol for an IDE study of the SOLAR System for the specific treatment of atrial fibrillation atrial fibrillation

Irregular rhythm (arrhythmia) of contraction of the atria (upper heart chambers). The most common major arrhythmia, it may result as a consequence of increased fibrous tissue in the aging heart, of heart disease, or in association with severe infection.
 ("AF"). No medical device on the market currently has FDA labeling for the treatment of AF.

Commenting on these developments, Marc Flores Flores, town, Guatemala
Flores (flōrəs), town (1990 est. pop. 2,200), capital of Petén department, N Guatemala. Flores was built on an island in the southern part of Lake Petén Itzá and on the site of the
, President and Chief Executive Officer of MedicalCV said, "We are pleased to be working with the FDA in this staged pathway to bring the SOLAR automated surgical ablation system to market quickly, with a clear road map toward obtaining a cardiac tissue indication while being in a position to drive revenues with our family of ablation products. The Company and its Scientific Advisory Board believe that our laser technology platform, as well as an innovative delivery mechanism to provide precise laser ablation for cardiac tissue, will be the key to providing definitive minimally invasive treatment for cardiac arrhythmias in the future."

About MedicalCV, Inc.

MedicalCV's ATRILAZE surgical ablation system utilizes laser energy for cardiac tissue ablation concomitant with both open-heart and minimally invasive cardiac surgery procedures. Physicians see precise cardiac ablation as a potentially effective way to address atrial fibrillation in certain patients. Atrial fibrillation, or AF, is the most commonly occurring cardiac arrhythmia. It reduces cardiac output cardiac output
n. Abbr. CO
The volume of blood pumped from the right or left ventricle in one minute. It is equal to the stroke volume multiplied by the heart rate.
, is a major precursor to congestive heart failure congestive heart failure, inability of the heart to expel sufficient blood to keep pace with the metabolic demands of the body. In the healthy individual the heart can tolerate large increases of workload for a considerable length of time.  and is associated with an increased incidence of stroke.

MedicalCV's SOLAR automated surgical ablation system, which is the subject of the pending FDA clearance, utilizes laser energy to ablate ab·late
v.
To remove or destroy the function of.



ablate

to remove, especially by cutting.

ablate verb To remove; excise
 soft tissue in various surgical settings.

This release contains certain forward-looking statements of expected future developments, as defined in the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  of 1995. The forward-looking statements in this release refer to the Company's expectations regarding the development, regulatory clearance and commercialization of its automated surgical ablation system. These forward-looking statements reflect management's expectations and are based on currently available data; however, actual results are subject to future risks and uncertainties, which could materially affect actual performance. Risks and uncertainties that could affect such performance include, but are not limited to, the following: the Company's ability to fund significant capital needs; the ability to gather acceptable clinical data in a timely manner to support regulatory clearances; the ability of the Company's capital goods Capital Goods

Any goods used by an organization to produce other goods.

Notes:
Examples of capital goods include office buildings, equipment, and machinery.
See also: Capital Expenditure, Disinvestment



Capital goods
 suppliers to provide it with suitable clinical product; competing technological and market developments; physician acceptance of the Company's cardiovascular products; dependence upon governmental reimbursements and third party suppliers; and the strength of the market for cardiovascular products. For more detailed information about these risks and uncertainties, please review the Company's Annual Report on Form 10-KSB, as filed with the Securities and Exchange Commission on July 20, 2006.

These events and uncertainties are difficult or impossible to predict accurately and many are beyond the Company's control. The Company assumes no obligation to publicly release the results of any revisions that may be made to any forward-looking statements to reflect events or uncertainties after the date of such statements or to reflect the occurrence of anticipated or unanticipated events.
COPYRIGHT 2007 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2007, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

 Reader Opinion

Title:

Comment:



 

Article Details
Printer friendly Cite/link Email Feedback
Publication:Business Wire
Date:Jan 3, 2007
Words:722
Previous Article:Applica Enters into Fourth Amendment to Merger Agreement with Harbinger Capital Partners.
Next Article:Metretek Technologies Names President and CEO of Florida Subsidiary.
Topics:



Related Articles
MedicalCV, Inc. to Present at Medtech Insight and Windhover Information's ``Investment In Innovation (In3) WEST'' Conference, February 23-24, 2006.
ESTECH Launches the COBRA Adhere XL, a New Cardiac Ablation Product Offering an Alternative Treatment With Proven Safety and Effectiveness.
MedicalCV, Inc. Appoints Eapen Chacko as Chief Financial Officer; Senior Financial Executive Brings 30 Years of Experience to MedicalCV.
MedicalCV, Inc. Delays Proposed Public Offering.
MedicalCV to Present at the C.E. Unterberg, Towbin Emerging Growth Conference.
MedicalCV's ATRILAZE(TM) and SOLAR(TM) Systems Highlighted at 10th Annual NewEra Cardiac Care 2007 Meeting.
MedicalCV Elects Two Senior Medical Device Executives to Its Board of Directors.
MedicalCV, Inc. Receives FDA 510(k) Clearance for Its SOLAR(TM) Surgical Ablation System.
MedicalCV, Inc. Announces Completion of 1st Robotic Lone Cardiac Ablation Procedure.
St. Jude Medical Announces Expanded European CE Mark to Include Therapy Cool Path Bi-Directional Irrigated Ablation Catheter; U.S. Approval for...

Terms of use | Copyright © 2009 Farlex, Inc. | Feedback | For webmasters | Submit articles