Medical Device Developer, MedQuest, Awarded ISO Certification

August 31, 2000 ,SALT LAKE CITY —MedQuest Products Inc. has been recently granted certification to meet ISO 9001 standards. The certification approves MedQuest’s quality assurance systems for the design and development of medical devices to meet international standards established by the International Organization for Standardization.

MedQuest is completing the development of HeartQuest: a revolutionary, magnetically-suspended, implantable blood pump. The patented HeartQuest pump offers heart failure patients improved reliability and longevity over existing mechanical blood pumps because it contains no friction-based internal parts. This feat can be accomplished because the HeartQuest blood pump has a rotor completely suspended in a magnetic field, eliminating mechanical wear.

Each year in the United States, more than 250,000 people die from congestive heart failure, and more than a million are hospitalized. While heart transplantation is an option for some patients, only about 2,000 donor human hearts are annually transplanted. The limited life of existing blood pumps prevents their use in most heart failure patients. The HeartQuest device will immeasurably benefit heart failure patients in desperate need of a cost-effective, reliable, small blood pump that provides a high quality of life. Mr. Paul Diegel, Project Manager, states, “the HeartQuest blood pump will be initially introduced to assist the failing left ventricle, meeting the needs of 80% of such patients.” In this application, a blood pump is commonly known as a Left Ventricular Assist Device (LVAD).

An implantable-size, magnetically-suspended HeartQuest LVAD prototype has already been designed, assembled, and tested. The design for clinical use is being completed. The clinical HeartQuest LVAD will be tested in animals by the end of this year.

The HeartQuest LVAD development will continue to be supported through funding by the LDS Hospital-Deseret Foundation’s Heart & Lung Research Foundation based in Salt Lake City, Utah. This philanthropic-based support has been complemented by a recent 4-year, $4.2 million National Institutes of Health (NIH) grant. The HeartQuest is the only blood pump funded by such a NIH grant. The team expects to soon obtain additional financial support to enable clinical use of the HeartQuest blood pump in 2002.

Ms. Holly Imes, Quality Assurance & Regulatory Affairs Manager at MedQuest, says “this quality system certification is a significant milestone on our outlined pathway to meet the stringent regulatory approvals for the HeartQuest LVAD both in the United States and in Europe.” The ISO 9001 certificate was awarded by BSI America Inc. of Reston, Virginia, an affiliate of the British Standards Institution.

MedQuest has already commercialized a medical device, the single-use, AuTome electrosurgical electrode (commonly known as an “cautery knife” and used extensively by surgeons for cutting and coagulation during surgery), based on technology developed for the HeartQuest blood pump: an innovative and patented biocompatible coating, QuestCoat. The AuTome blade has received FDA 510(k) clearance, and is being sold for clinical use in Asia and in the United States.

Mr. Pratap Khanwilkar, MedQuest’s co-founder and President, and an American Society of Quality certified professional, says, “the ISO certification affirms the value of MedQuest’s quality philosophy, policy, and systems. It endorses our view that building quality in MedQuest from the start not only allows us to meet international standards at a relatively early stage of our growth, but also positions us for greater commercial success in the future.”

Company Background
MedQuest is a pioneer in the development of implantable ventricular assist devices (VADs). The HeartQuest™ VAD is an implantable, centrifugal pump that utilizes a magnetically suspended impeller to provide a frictionless, wear-free pumping action. A VAD boosts the output of a failing heart to normal levels. Congestive heart failure is the fastest growing segment of the cardiovascular disease market and is diagnosed in 550,000 Americans each year; over 200,000 deaths annually are attributed to congestive heart failure according to American Heart Association 2002 statistics .

MedQuest®, HeartQuest™, and MagLev™ are trademarks of MedQuest® Products Inc.