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MOGUL ENTERPRISES, Inc. Receives FDA Clearance to Market Its Astra I and Astra II -- 4 and 5 French -- Electrophysiology Diagnostic Catheters.


Business Editors/Health/Medical Writers

SAN JOSE San Jose, city, United States
San Jose (sănəzā`, săn hōzā`), city (1990 pop. 782,248), seat of Santa Clara co., W central Calif.; founded 1777, inc. 1850.
, Calif.--(BUSINESS WIRE)--July 14, 2003

MOGUL ENTERPRISES, Inc. (A privately held corporation Noun 1. privately held corporation - a corporation owned by a few people; shares have no public market
close corporation, closed corporation, private corporation
) today announced that it received US Food and Drug Administration clearance of its 4 & 5 French, up-to-10-electrode electrophysiology electrophysiology /elec·tro·phys·i·ol·o·gy/ (-fiz?e-ol´ah-je)
1. the study of the mechanisms of production of electrical phenomena, particularly in the nervous system, and their consequences in the living organism.

2.
 diagnostic catheters to be marketed respectively as Astra(TM) I & Astra(TM) II. The clearance includes steerable and fixed-curve distal shaft versions of the catheter designs.

Jamil Mogul, CEO/Chairperson of MOGUL ENTERPRISES, Inc., stated, "During electrophysiology (EP) study, our innovative 4 & 5 French steerable/fixed-curve EP diagnostic catheters with up to ten electrodes Electrodes
Tiny wires in adhesive pads that are applied to the body for ECG measurement.

Mentioned in: Electrocardiography
 will provide physicians with advantageous features, superior performance and price affordability. The Astra(TM) I and Astra(TM) II catheters add to our exquisite product portfolio, which includes our other FDA-cleared EP diagnostic catheters (3-French steerable/fixed-curve EP catheters with up to 10 electrodes & 6-French steerable/fixed-curve EP catheters with up to 20 electrodes), and contain the following main features:

-- The catheter shaft sizes are 4 French (.053 inch nominal) and

5 French (.066 inch nominal)

-- The distal shaft contains up to ten recording electrodes to

encompass a wider intracardiac intracardiac /in·tra·car·di·ac/ (-kahr´de-ak) within the heart.

in·tra·car·di·ac
adj.
Within the heart.



intracardiac

within the heart.
 region

-- The steerable distal shaft has two versions: unidirectional The transfer or transmission of data in a channel in one direction only.  

and bi-directional, to more easily access and consistently

diagnose different intracardiac regions in a given cardiac

chamber

-- The fixed-curve distal shaft has a conventional or custom

curve, per the physician's requirement

-- The distal shaft has various optional lengths, up to 6.0

inches, to conform to Verb 1. conform to - satisfy a condition or restriction; "Does this paper meet the requirements for the degree?"
fit, meet

coordinate - be co-ordinated; "These activities coordinate well"
 heart chamber variations

-- The recording electrodes have various lengths and are offered

with various inter-electrode spacing

-- Both the distal and proximal shafts come in soft or stiff

material option for better catheter handling

-- The proximal shaft is wire-braided with a proprietary design

for better torque transmissibility trans·mis·si·ble  
adj.
That can be transmitted: transmissible signals.



trans·mis
"

MOGUL ENTERPRISES, Inc. is a highly experienced medical company dedicated to developing innovative and inexpensive medical devices/instrumentation related to cardiovascular Rx/Dx and minimally invasive, general surgeries for fulfilling the needs of budget-constrained hospitals and cost-conscious customers in the USA, Europe, Japan and emerging-market countries.

Jamil Mogul stated, "We believe that affordability of all our EP catheters and the other medical devices and instrumentation that are under development at MOGUL ENTERPRISES, Inc. will help provide an access of modern diagnostic, therapeutic/surgical procedures to millions of patients in small cities/towns in the USA, Canada, Europe, Asia, Africa, Latin (North & South) America, Australia and New Zealand New Zealand (zē`lənd), island country (2005 est. pop. 4,035,000), 104,454 sq mi (270,534 sq km), in the S Pacific Ocean, over 1,000 mi (1,600 km) SE of Australia. The capital is Wellington; the largest city and leading port is Auckland.  as well."

He also indicated, "Our 4 & 5 French electrophysiology diagnostic catheters will be cost competitive so as to be affordable to the cost-conscious physicians and the budget-constrained hospitals that have a great need of electrophysiology catheters of these sizes with up to ten electrodes in their cardiac catheter cardiac catheter
n.
A long, fine catheter that can be passed into the chambers of the heart via a vein or artery as a means of withdrawing samples of blood, measuring pressures within the heart's chambers or great vessels, or injecting contrast media.
 laboratories. These catheters will generally be priced 30% below the competition while offering more features and better performance than the competitive catheters in these French sizes."

MOGUL ENTERPRISES, Inc. needs to expand its facility to produce these catheters in a high volume for commercialization. Therefore, it is searching for investment partners to join the company and receive a generous profit share and/or company stocks in exchange for their financial investment. Simultaneously, it intends to offer an exclusive license on a territory basis to manufacture and/or distribute the catheters.
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Publication:Business Wire
Date:Jul 14, 2003
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