BBI Contributing Editor

ORLANDO, Florida – Among the companies that seemed to have their marketing act together at this year's American College of Cardiology (ACC; Bethesda, Maryland) gathering was up-and-coming CardioDynamics (San Diego, California), maker of the BioZ noninvasive cardiac output monitor.

With the decline of both of its major competitors, Renaissance Medical and Sorba – one of which went into bankruptcy and the other of which has not been able to capitalize on the market opportunity as well as Cardiodynamics – the company has experienced dramatic growth over the last 2 1/2 years, since its alliance with GE Marquette Medical (formerly Marquette Medical) began. CardioDynamics has worked with that company to make the device a success, and was showing its new GE noninvasive BioZ plug-in for the first time at ACC. This provides a module for the GE monitoring system that provides more features than the $25,000 stand-alone device CardioDynamics already was selling successfully through the GE sales organization. It should open up the market even further by providing both a more convenient and cost-effective solution for these important parameters.

Another go-getter, Quinton (Bothell, Washington), was showing its newly enhanced Q-Cath lab recording system software version 4.7. It is HL7-compatible, allowing it to interact directly with the admit, discharge and transfer computer systems installed in most hospitals. It includes a procedure inventory management system that was certified compliant with the ACC database, and featured physician 2000 voice dictation for transcription of pre and post-procedure notes by doctors and nurses. The system includes a patient record repository, and supports multiple cath labs simultaneously. The system ranges in price from around $90,000 to about $120,000, depending on the hardware configuration. The Society of Thoracic Surgeons (STS) database is an extra cost option. In spite of the success of Sentillion at this year's Healthcare Information and Management Systems Society (HIMSS; Chicago, Illinois) meeting, the reaction of Quinton to clinical context object workgroup compliance (CCOW)-enabled technology was cool. While initially excited about the prospects of integrating its data with the rest of the cardiology department, Quinton seemed to now believe that what customers want is not visual integration (provided by HL7-CCOW) but data integration, via clinical repositories. This makes CCOW less important than it once was to Quinton, as evidenced by the fact that it said the newest Q-Cath was not CCOW compliant, and the company did not plan to make it compliant anytime soon.

Quinton also was showing its new Q-Stress digital Holter system, which works with analog and new, EASI 12-lead digital Holter recorders. This PC-based workstation had an entry price, with software, of around $20,000. One unique feature of its report generator is that it generates HTML-formatted reports that can be immediately e-mailed to the referring physician or posted directly to a secure web site and viewed by any authorized physician whose computer is equipped with a web browser. Quinton was spun off from parent American Home Products (Madison, New Jersey), a company that never seemed to understand the medical instrument business segments, and provided little support to Quinton. Since the spin-off, some interesting new products have emerged, and the management of the company has become focused and aggressive. We expect to see more of this company in the near future, now that it is a private firm again. One important key to success is that Quinton has good access to big national accounts such as Tenet, HCA-Columbia and Premier.

Other new entries in the Holter/cardiac event recorder market came from Instromedix (San Diego, California). Since being divested by Alaris Medical (also San Diego) and acquired by Card Guard, Instromedix has regained some product focus, and was showing some new products. One of these is the LifeSigns System, which ushers in a breakthrough in telecardiology, by delivering hospital-grade vital signs monitoring in an outpatient, rehab or home care setting. Designed for rapid access and timely assessment of a patient's condition, the easy-to-use system enables efficient transmission of vital information, utilizing new communications technology to connect patient, physician and medical facility. This portable unit provides 12-lead ECG, pulse oximetry and non-invasive blood pressure, in a small, battery-operated, portable format. By dropping it into a "shuttle bay," the unit uploads its stored information to a central station workstation and repository. The remote workstation provides on-screen 12-lead ECG, SpO₂ and blood pressure monitoring systems, providing a complete patient record including history and physical assessment, allergies, medications, therapies and progress notes. Current and previous physician orders can be displayed on one screen at the remote central monitoring location.

The Lifesigns Micro12 ECG device makes clear that more than the hospital-based, portable monitoring companies such as Welch Allyn Protocol, MDE and others are interested in the alternate-site monitoring market that is developing to treat heart failure, respiratory and other ambulatory patients with chronic illnesses. The unit can take up to 40 snapshots, each 12 seconds in duration, before it runs out of memory and has to be uploaded. This new device may be ideal for use in correctional facilities where the remote surveillance is outside of the prisoner's secured areas.

On the therapeutic side, Cardiomedics (Irvine, California) was showing the latest version of its "cardiac pants," the external, heart-synchronized, inflatable pants that augment the heart's own pumping action and are used to treat angina and stroke. This is an outgrowth of the Zheng device, developed in China and used extensively at the State University of New York at Stony Brook. Vasomedical (Westbury, New York) began importing the Chinese device in 1995 following the FDA's clearance to market based on substantial equivalence to the CardiAssist device. Despite an extensive amount of clinical study on the subject over the past 45 years, Cardiomedics said it intends to conduct a minimum of three multicenter studies to enhance external counterpulsation's acceptance by the medical profession, to obtain reimbursement for its use and for possible future regulatory purposes.

Cardiomedics also competes with Hypertension Diagnostics (Eagen, Minnesota), which makes a similar unit. The companies fight it out over issues like patient comfort and therapy time. Data from recent studies indicates that this device can be effective in half the time now thought to be required by competitive units, which will allow twice as many patients to be treated by any provider. The procedure is now reimbursable. If Cardiomedics can convince providers of this advantage, it could capture a larger market share than it currently holds.

Fukuda Denshi (Irvine, California) used ACC to introduce its new LX-5120 telemetry transmitters, designed to work at 608-614 MHz. With this introduction, Fukuda joins Data Critical, Agilent, Spacelabs and other companies offering wireless medical telemetry system (WMTS) products.