Micropace is proud to announce the regulatory clearance for sale in Japan of its EPS320 Touch screen cardiac stimulator for distribution by Medicon, Inc. a Japanese distributor of medical equipment partly owned by C.R. Bard, Inc.
Micropace plans to increase sales in 2008 by serving the Japanese market with bundled and stand alone sales of its stimulators.
The EPS320 with software 3.20SR3 is a two channel, (optionally expandable to four channels) computerized digital cardiac diagnostic stimulator used during electrophysiological studies. The EPS320 was designed by an electrophysiologist, features accurate, reliable and safe stimulation with a highly intuitive interface able to be learned by staff within minutes. The EPS320 and its preceding models have been highly successful in the US and European markets since 2000. With almost 600 units sold in the US and 900 units worldwide, recent annual sales have made the EPS320 the No.1 selling EP diagnostic stimulator in the US market.
Micropace announces the clearance for sale in the USA by FDA of its new StimLab™ Cardiac Stimulator, following clearance for the EU market in the previous month. The StimLab™ is a robust flexible EP laboratory-wide cardiac stimulation system, incorporating a fully featured bedside touch screen stimulator controller.
Other companies have answered to physicians' long standing requests for bedside control over stimulation with limited controls such as foot pedals to start/stop pacing, simple controls to adjust pacing or just slave monitors. Micropace is the first to provide full bedside display and control over stimulation in a hot-connectible unit which is able to be mounted either on a roll stand, on a bed rail or on a suspension arm and which is connected with a single robust quick-disconnect plug connector.
The StimLab™ is available through our normal distribution channels bundled with new EP laboratories or as a new stand alone purchase. Micropace will support exiting customers wishing to upgrade to a StimLab™ with trade-in offers for older Micropace stimulators.
Micropace has opened its US Headquarters on 1 March 2007 at:
Suite K, Building 3
1582 Parkway Loop,
Tustin CA 92780
US branch Objectives
- Serve and facilitate customer needs in upgrading of obsolete hardware stimulators in US Hospitals.
- Provide a local product supply & delivery, support, service and education for our US distributors – GE Healthcare & Bard EP, and end-customers.
- Move appropriate production steps to the US.
Micropace US Branch services will include:
- Stocks of Micropace stimulator systems for urgent local delivery.
- Micropace Field Replacement Units (FRU) for urgent delivery to distributor or directly to hospitals.
- Stocks of demonstration systems for use by distributors.
- Facility for product demonstration, installation and training in case of urgent need by distributors.
- Phone support, on-site and back to base support for hospitals and distributors by troubleshooting and component replacement.
In response to new market demands for our cardiac stimulators in the USA, Micropace is establishing an US office “Micropace EP, Inc” to be located in Tustin, CA by early 2007. The office will initially offer logistic services for urgent orders and product support resources for distributors and customers where needed.
Micropace has commenced development of an interactive web based Micropace eLearning certification program. The program will be marketed to EP lab managers to certify their staff in the safety and functional aspects of diagnostic cardiac stimulation in general and on Micropace products in particular.
A recently circulated Boston Scientific internal company test report (M.Pare et al, 24.July 2006) showed that a popular hardware EP stimulator exhibited potentially arrhythmogenic nett DC voltages on its pacing outputs when the pacing bipole is located near the ablation catheter during delivery of RF ablation energy. [This is presumably due to partial rectification by non-linear elements in output circuits.] This hazard was found to be mitigated by RF filters in some EP recorders, otherwise mitigation by a separate RF filter in the pacing circuit was recommended.
For the information of our customers, Micropace stimulators do not pose a hazard in the presence of RF ablation energies and may be left connected to patients during RF ablation.
Micropace has been aware of this issue since 2001 and Micropace stimulators have RF filters in their stimulus connection boxes and do not exhibit DC voltage on its outputs during RF energy delivery. Some early stimulators sold outside of the US prior to Jan 2001 do not have RF filters but rely on a general 'DC Current Alarm' safety cutout feature present in all Micropace stimulators, to detect and interrupt flow of any potentially hazardous DC currents in its output circuit. Micropace has performed in-vitro experiments similar to those by Boston Scientific since this paper was released and confirmed the absence of output DC voltages on the EPS320.
Owners of Micropace stimulators therefore do not need to take any specific action in response to these issues. Customers are neverthelsss reminded to read carefully and always follow the Warnings and Precautions in the Essential Prescriber Information section of their EPS320 User Instruction Manual - download here.
Micropace is nearing completion of testing on the Stimlab™ dual touch screen stimulator system, which will now be submitted for regulatory approval. This system allows simultaneous dual touch screen control of cardiac stimulator from the control room and by the physician at the bedside. The bedside touch screen may be fixed permanently or may be on a wheeled platform, which can be disconnected at a single connector and stowed between EP cases. The system is awaited by teaching institutions for teacher-pupil training as well as non-teaching EP labs, where the system gives flexibility for the physician to perform own stimulation due to staffing issues or personal preference.
Micropace has responded to growing demands for its product following recent events involving Fisher imaging and its Bloom Electrophysiology Programmable Stimulator. Micropace has further increased production, currently 40% higher compared to previous year period. Micropace has also completed testing on Software Ver 3.21, which now supports the specialised functions provided by this hardware stimulator, allowing seamless transition to the Micropace software platform by even the most demanding users. The new features include:
- facility for near-simultaneous 4 channel pacing,
- implementation of multiple drive trains in addition to existing ATP protocol and
- AV sequential S1 drive train pacing mode for extra-stimuli.
A cross-platform instruction booklet will facilitate cross-training.
Micropace and GE Healthcare partnership strengthens with a decision by GE Healthcare to offer a specifically GE configured Micropace EPS320 Cardiac Stimulator as a default stimulator with the CardioLab II. All Micropace stimulator shipments by GE Healthcare will now automatically contain the popular touch screen and four channel options, together with specific configuration optimised for the CardioLab II EP recording system.
Micropace announces release of a service release to its Touch Screen software Ver 3.20, featuring:
- Multilanguage software interface support – including French, German, Italian and Spanish software screens, menus and help files.
- New easier method of software upgrade via USB Flash drive
- Improved touch screen calibration menu
- Correction of issue of rare software freeze.