Printer Friendly

ADVANCED INTERVENTIONAL SYSTEMS RECEIVES FDA PRE-MARKET APPROVAL

 ADVANCED INTERVENTIONAL SYSTEMS RECEIVES FDA PRE-MARKET APPROVAL
 First Laser Angioplasty System to Be Approved
 for Coronary Laser Angioplasty
 IRVINE, Calif., Jan. 31 /PRNewswire/ -- The federal Food and Drug Administration has granted pre-market (PMA) to Irvine-based Advanced Interventional Systems (NASDAQ: LAIS) for its DYMER(R) 200+ excimer laser angioplasty system. This is the first laser angioplasty system to be approved for use in the coronary arteries and makes this new technology available for widespread use throughout use the United States.
 The DYMER 200+ is used to perform percutaneous excimer laser coronary angioplasty (ELCA)(TM). An estimated 3,000 patients worldwide suffering from coronary artery disease have participated in ELCA clinical trials, with an overall procedural success rate of approximately 90 percent.
 "In human applications, ELCA has proven to be safe and efficacious in treating coronary blockages that are 20 millimeters or longer," said Robert Wall, Advanced Interventional Systems chairman. "Our data suggest that ELCA is particularly well suited for certain difficult lesions unfavorable for standard balloon angioplasty. This technology truly expands the number of patients that can be successfully treated by interventional cardiologists.
 "We were honored and greatly appreciated the contribution made by leading cardiologists from major angioplasty centers worldwide who participated in the ELCA trials," Wall says.
 ELCA Expands Less Invasive Cardiac Treatment
 Today, approximately 300,000 patients in the United States per year undergo percutaneous transluminal coronary angioplasty (PTCA - commonly known as balloon angioplasty) to clear blocked arteries, although angioplasty has been found to have limited success treating long lesions. In addition, for many of the 270,000 patients treated with coronary bypass surgery each year in the United States that have coronary blockages longer than 20 mm which are difficult to treat by PTCA, ELCA performed on the Advanced Interventional Systems system, provides a new alternative.
 During ELCA, laser energy is transmitted through a fiber-optic based catheter and administered in pulses, until it literally breaks down the plaque molecules into a mixture of gases and liquid and micro-miniature particulate form that is carried through the bloodstream and eliminated in the body's natural waste system.
 The precise ultraviolet excimer laser causes no recognizable change in surface temperature, thereby minimizing vessel wall trauma providing a greater margin of safety for coronary applications than other lasers, which are still in the investigational stages. Although the excimer is capable of cutting through bone, its cool energy makes a clean, precise cut without significant unintended damage to adjacent tissue.
 "The FDA approval of the Advanced Interventional Systems DYMER 200+ will make the ELCA procedure available to potentially thousands of patients suffering from coronary artery disease," Wall concluded.
 Advanced Interventional Systems pioneered excimer laser angioplasty and is the technological leader in the development of laser systems for cardiovascular applications. The company was founded in 1986. In November 1991, Advanced Interventional Systems completed its initial public offering.
 -0- 1/31/92
 /NOTE: Photo is being transmitted on the INS PhotoLink Network./
 /CONTACT: Connie McCluskey of Advanced Interventional Systems, 714-586-1342/
 (LAIS) CO: Advanced Interventional Systems Inc. ST: California IN: MTC HEA SU:


EH-KJ -- LA015 -- 5704 01/31/92 15:05 EST
COPYRIGHT 1992 PR Newswire Association LLC
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1992 Gale, Cengage Learning. All rights reserved.

Article Details
Printer friendly Cite/link Email Feedback
Publication:PR Newswire
Date:Jan 31, 1992
Words:515
Previous Article:GENERAL MILLS ANNOUNCES MANAGEMENT CHANGES
Next Article:STAR EDITOR VOWS TO UNVEIL HIS MAGAZINE'S NEW ALLEGATIONS BY GENNIFER FLOWERS AGAINST BILL CLINTON TONIGHT ON CNBC'S 'TALK LIVE'
Topics:


Related Articles
ADVANCED INTERVENTIONAL SYSTEMS ADDS NEW CATHETER TO CLINICAL TRIALS WITH EXCIMER LASER SYSTEM
ADVANCED INTERVENTIONAL SYSTEMS REPORTS FISCAL 1991 RESULTS; FINANCIAL PERFORMANCE CONSISTENT WITH RECENT ANALYST PROJECTIONS
ADVANCED INTERVENTIONAL SYSTEMS RECEIVES MARKETING APPROVAL FOR SECOND GENERATION LASER
ADVANCED INTERVENTIONAL SYSTEMS RECEIVES MARKETING APPROVAL FOR TWO OF ITS 50-MICRON FIBEROPTIC-BASED CATHETERS
ADVANCED INTERVENTIONAL SYSTEMS ANNOUNCES SECOND QUARTER RESULTS
ADVANCED INTERVENTIONAL SYSTEMS ANNOUNCES VICE PRESIDENT OF SALES
ADVANCED INTERVENTIONAL SYSTEMS INC.WILL EVALUATE SPECTRANETICS PROPOSAL
QUEST MEDICAL REPORTS FDA CLEARANCE OF 510(K) SUBMISSION FOR THE MPS MYOCARDIAL PROTECTION SYSTEM
POSSIS MEDICAL, INC. RECEIVES FDA APPROVAL FOR PHASE 2 STUDY OF ANGIOJET CORONARY THROMBECTOMY SYSTEM
CardioGenesis Receives FDA Approval to Start Multi-Center Percutaneous, Myocardial Revascularization Clinical Trial

Terms of use | Copyright © 2016 Farlex, Inc. | Feedback | For webmasters