Vendor also files 510(k) application for intracardiac toolAcuson is planning a move into the low and mid-range cardiovascular ultrasound markets. The ultrasound firm has signed a definitive agreement to acquire Ecton, a privately held company that
Vendor also files 510(k) application for intracardiac tool
Acuson is planning a move into the low and mid-range cardiovascular ultrasound markets. The ultrasound firm has signed a definitive agreement to acquire Ecton, a privately held company that is developing a portable, miniaturized echocardiography platform.
The work-in-progress Ecton system includes an all-digital phased array and will sell for $40,000 to $60,000, aiming for a price point that would tap into an estimated $300 million worldwide market for low-to-mid-range cardiac systems, according to Acuson. It will also allow Acuson to broaden its reach into emergency room, operating room, mobile, cardiac care, and remote environments.
All ultrasound modes and stress echo will be included on the system, as will advanced sonographic features like harmonic imaging, according to Bill Varley, Acusons vice president of worldwide marketing for cardiology.
In addition, the system will feature embedded DICOM communications, with extensive internal digital study storage for archiving patient studies in a high-resolution digital format.
Theyve designed the system to function in a digital lab environment, Varley said.
Shipments of the Ecton system, which weighs less than 20 pounds, are expected to begin in the second half of next year. Ecton has already received Food and Drug Administration 510(k) clearance for the system, and has applied for a CE Mark for clearance in Europe.
Acuson will focus initially on the echocardiography market with the system, but may apply the technology to other imaging markets in the future, Varley said. The unit will complement other Acuson platforms currently sold in the cardiac ultrasound sector. Aspen sells for $90,000 to $150,000, while Sequoia is priced from $190,000 to $300,000, depending on configuration.
As it stands now, the stock purchase of Ecton is valued at $23 million. In addition, up to $17 million may be payable, depending on operating results achieved by Plymouth Meeting, PA-based Ecton through 2003. The transaction is structured as a tax-free exchange of stock, and will be accounted for as a purchase. Closing is expected next month.
Ecton will become the Small Systems division of Acuson, and will remain at its Plymouth Meeting facility. Ecton president Michael Cannon will continue as general manager of the division.
The planned purchase of Ecton wasnt the only development in echocardiography for Acuson last month. The company announced that it had filed a 510(k) application with the FDA for AcuNav, a miniaturized ultrasound catheter that will allow physicians to visualize images from inside the heart without having to open the chest wall, according to the firm. The AcuNav catheter measures 3 1/3 mm in diameter and 90 cm long, and is equipped with a multifrequency transducer that scans with four independent frequencies ranging from 5.5 to 10 MHz.
With this technique, the AcuNav catheter is inserted through the femoral vein of the leg, then maneuvered into the right atrium or ventricle of the heart. At that point, the catheter acquires diagnostic images of the heart as well as Doppler blood flow information.
Physicians can view the entire heart from the right side, according to Acuson. This capability provides a complete view of all the hearts structures, and may reduce the risk of stroke, according to the firm.
Acuson has entered into a licensing agreement with the Mayo Clinic for AcuNav. Mayo Clinic and Acuson each hold a series of patents on this technology, which was initially conceived by two Mayo Clinic cardiologists and has been in development since 1991. Clinical trials conducted at Mayo have evaluated AcuNavs ability to visualize cardiac structures, blood flow, Doppler hemodynamics, and devices from within the heart. It will be available on both Aspen and Sequoia.
Acuson expects to launch AcuNav by the end of the year. It will first be available in the U.S. with other regions to follow over the next two years.
In other company news, Acuson has announced a two-year preferred provider contract with Mercy Resource Management. Acuson will be one of only two vendors approved to provide echocardiography, radiology, and vascular ultrasound systems, as well as image management products, to the healthcare providers 240 U.S. facilities. The agreement covers 128XP, Aspen, and Sequoia, as well as KinetDx, the firms new PACS offering (SCAN 5/12/99).