Printer Friendly
The Free Library
19,607,059 articles and books
Member login
User name  
Password 
 
Join us Forgot password?

Bayer Diagnostics and PharmaNetics Announce 510-k- Clearance For New Low Range Heparin Management Test -LHMT-.


Business & Health Editors

TARRYTOWN, N.Y./RALEIGH, N.C.--(BW HealthWire)--April 10, 2000

LHMT LHMT Lietuvos Hidrometeorologijos Tarnyba (Lithuanian Hydrometeorological Service)  Test Added to Rapidpoint(R) Coag Menu

Bayer Diagnostics and PharmaNetics, Inc. (NASDAQ NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
 NM: PHAR), the holding company of Cardiovascular Diagnostics, Inc. ("CVDI CVDI Certificado de Validación de Datos de Importadores (Argentina)
CVDI Crime Victims with Disabilities Initiative (California) 
"), today announced that 510(k) clearance was granted by the U.S. Food and Drug Administration (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.
) to market a new Low Range Heparin Management Test (LHMT). The test is based on PharmaNetics' Thrombolytic thrombolytic /throm·bo·lyt·ic/ (throm?bo-lit´ik) dissolving or splitting up a thrombus, or an agent that so acts.

thrombolytic

1. dissolving or splitting up a thrombus.

2. an agent that dissolves or splits up a thrombus.
 Assessment System (TAS) technology platform, which is marketed worldwide by Bayer Diagnostics as Rapidpoint(R)Coag.

The LHMT measures lower doses of heparin and will be used primarily in diagnostic and interventional cardiology procedures. The LHMT represents a niche $25-30 million test market. The American Heart Association American Heart Association (AHA),
n.pr a national voluntary health agency that has the goal of increasing public and medical awareness of cardiovascular diseases and stroke, and thereby reducing the number of associated deaths and disabilities.
 estimates three million diagnostic and interventional procedures, including angioplasty, stenting, and PTCA PTCA
abbr.
percutaneous transluminal coronary angioplasty


PTCA Percutaneous transluminal coronary angioplasty, see there
 were performed in the U.S during 1997. The importance of the test is that it completes Rapidpoint Coag's comprehensive menu of six tests for total heparin management used in numerous therapies, and various dosages, throughout the hospital.

In January, PharmaNetics' heparin management system received market clearance from the FDA for use primarily in cardiac bypass procedures with high dosages of heparin. Bayer expects to launch the heparin management system as Rapidpoint(R) Accent this summer.

"Clinical practices for various therapies require different dosing regimens. Consequently, diagnostic devices must be flexible enough to provide tests for these regimens in numerous patient care settings. The TAS provides a single platform that can be used with multiple test cards to rapidly monitor heparin as well as other antithrombotic agents throughout their therapeutic range," said John Funkhouser, President and Chief Executive Officer, PharmaNetics. Funkhouser continued, "While the LHMT completes the heparin menu, PharmaNetics' ultimate goal is to provide management tools for physicians utilizing any therapeutic affecting coagulation coagulation (kōăg'ylā`shən), the collecting into a mass of minute particles of a solid dispersed throughout a liquid (a sol), usually followed by the precipitation or . Earlier this year, the Company announced the development of two menu extensions to monitor platelet inhibitors and low molecular weight heparin In medicine, low molecular weight heparin (LMWH) is a class of medication used as an anticoagulant in diseases that feature thrombosis, as well as for prophylaxis in situations that lead to a high risk of thrombosis. , two classes of drugs that are being used increasingly to prevent thrombosis."

"Bayer Diagnostics is strongly committed to the point-of-care coagulation market," said Fran Tuttle, Senior Vice President and General Manager, Critical Care Diagnostics, Bayer Diagnostics. "We have, and will continue to support research and development of new tests for Rapidpoint Coag. Today, Bayer Diagnostics offers the broadest menu of coagulation tests available on a single unit." Ms. Tuttle continued, "In addition, the launch of Rapidpoint Accent, expected later this year, will enhance Bayer's presence in the cardiac surgery market by offering the surgical staff a fully automated heparin management system."

Heparin is currently the major drug used to control blood clotting in patients undergoing procedures such as diagnostic cardiac catheterization and interventional procedures which include balloon angioplasty and stent placement. Because it is widely used, heparin is responsible for more bleeding complications in hospital patients than any other drug. The need for heparin management is because the response of different patients to the same dose of heparin can vary widely. Of particular importance in interventional cardiology is the need to reliably monitor heparin down to a safe level at the end of the procedure to allow removal of the arterial sheath without substantial bleeding. Thus, there is a requirement for the LHMT test.

Headquartered in Tarrytown, New York Tarrytown is a village in Westchester County, New York, United States. The population was 11,090 at the 2000 census.

The Village of Tarrytown is located in the northwest part of the Town of Greenburgh, New York.
, Bayer Diagnostics, (www.bayerdiag.com), is one of the largest diagnostic businesses in the world. With more than 7,500 employees worldwide and 1998 sales of close to $1.8 billion, the company serves customers in 100 countries with a breadth of diagnostics technology in the areas of nucleic acid diagnostics, cardiovascular disease management, oncology, virology and blood glucose monitoring blood glucose monitoring Sugar monitoring Lab medicine The periodic testing of serum glucose in Pts known to have DM. See Bedside glucose monitoring, Beta cell implants, Diabetes, Glucometer, Glycosylated hemoglobin, Non-Invasive glucose monitoring. . Bayer Diagnostics is a division of Bayer Corporation and a member of the worldwide Bayer Group, a $31 billion international life sciences, polymers and specialty chemicals group based in Leverkusen, Germany. With headquarters in Pittsburgh, Bayer Corporation is a research-based company with major businesses in health care, life sciences and chemicals.

PharmaNetics, Inc. develops, manufactures and markets rapid turnaround diagnostics to assess blood clot formation and dissolution. The Company develops tests based on its proprietary, dry chemistry Thrombolytic Assessment System for its principal target market of powerful new drug compounds, some of which may have narrow therapeutic ranges, as well as for monitoring routine anticoagulants Anticoagulants
Drugs that suppress, delay, or prevent blood clots. Anticoagulants are used to treat embolisms.

Mentioned in: Embolism, Heart Valve Replacement
. The Company's therapeutic diagnostics are used to monitor the effect of antithrombotic agents in the treatment of angina, myocardial infarction (heart attack), stroke, deep venous thrombosis deep venous thrombosis
n. Abbr. DVT
A condition in which one or more thrombi form in a deep vein, especially in the leg or pelvis, resulting in an increased risk of pulmonary embolism.
, and pulmonary and arterial emboli emboli /em·bo·li/ (em´bo-li) plural of embolus.
Emboli
Plural of embolus. An embolus is something that blocks the blood flow in a blood vessel.
.

This press release contains forward-looking statements regarding future events and the future performance of PharmaNetics that involve risks and uncertainties, such as risks related to market acceptance, clinical trials and dependence on third-party distributors and collaborative partners that could cause actual results to differ materially from those projected in the forward-looking statements. Information concerning these and other factors that could cause actual results to differ materially from those in the forward-looking statements is contained in the Company's SEC filings, including Form 10-K, Form 10-Q and Form 8-K reports.
COPYRIGHT 2000 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2000, 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:Apr 10, 2000
Words:819
Previous Article:Action Performance Signs Exclusive Agreement With Nine-Time NHRA Funny Car Champ John Force.
Next Article:Ispat International Enters Into Strategic Marketing Alliance With e-STEEL.



Related Articles
Pharmanetics Initiates Comparative Studies With ECT Test; Cleveland Clinic And Duke University To Monitor Aventis' Drug.
PharmaNetics Heparin Management Panel Approved by FDA.
PharmaNetics Single Use Controls Cleared by FDA; Completes Regulatory Clearance for Rapidpoint Accent System.
PharmaNetics Initiates Clinical Testing of Rapid Test to Monitor Low Molecular Weight Heparin.
PharmaNetics Reports First Quarter Results.
PharmaNetics Announces Launch by Bayer Diagnostics of Rapidpoint Accent - Heparin Management System.
BAYER TO ACQUIRE VISIBLE GENETICS FOR $61.4 MILLION IN CASH.
Fatal spontaneous retroperitoneal hematoma secondary to enoxaparin. (Case Report).
Data Presented at AmSECT Demonstrates Significant Advantages of PharmaNetics Heparin Management Panel in Cardiopulmonary Bypass Procedures.
New anticoagulants show promise.

Terms of use | Copyright © 2012 Farlex, Inc. | Feedback | For webmasters | Submit articles