Results from the first 2 patients with ISSYS wireless implantable hemodynamic monitor and LVAD will be presented at the 7th Branislav ‘Brano’ Radovancevic International Heart Failure Forum.
Michigan, USA, September 10, 2014: Integrated Sensing Systems, Inc. (ISSYS) announced today that the results from the first 2 patients with an LVAD (Left Ventricle Assist Device) together with an ISSYS miniature wireless implantable hemodynamic monitor (IHM) will be presented at the 7th Branislav ‘Brano’ Radovancevic International Heart Failure Forum, September 17th-20th; Opatija, Croatia. The presentation, entitled “Wireless intracardiac pressure sensor for monitoring of LVAD function- a first in man study” will be presented by Professor Henrik Ahn (Linkoping University, Linkoping, Sweden) on Friday, September 19th, 2014 at 11:10 AM.
ISSYS’ wireless IHM distinguishes itself by being able to monitor the left side of the heart. Being able to noninvasively monitor the left atrium on demand provides invaluable information for intelligent adjustments of LVAD settings and also allows improved chronic patient management with advanced features such as home monitoring capability and on demand wireless data capture. A custom-made internet database allows the patients to submit the home monitored cardio waveforms to a database which provides medical staff the means to read the patient’s data, at will, anywhere in the world. The ISSYS wireless IHM system also allows long-term monitoring (i.e., Trending) of important parameters such as Filling Pressure.
Professor Ahn is the medical principal investigator of the clinical study for the use of ISSYS IHM devices in patients with congestive heart failure. This on-going clinical study recently finished its first year with excellent results in both safety and efficacy categories. Professor Ahn stated that “The sensor implantations have been very straightforward and the measurements are easy to carry out even for the elderly patients. We have not observed any device-related complications and so far the sensors have worked very well.”
Dr. Nader Najafi, ISSYS President and CEO, stated that, “the early results are promising and may lead to the use of ISSYS IHM implants as the standard of care for LVADs. More advanced LVAD systems consisting of two ISSYS IHMs to monitor two heart chambers have also been considered for further development.” ISSYS implants are able to monitor left atrium, left ventricle, or pulmonary artery pressures and can be implanted by two distinct methods: surgical implants (adjunct to an already established surgery), or interventional implants (delivered via a catheter).
ISSYS Background: ISSYS is a leader in advanced MEMS technologies for design and manufacturing of industrial, medical, microfluidic and scientific analytical sensing applications. Founded in 1995, ISSYS is one of the oldest independent MEMS companies in the US. ISSYS operates a comprehensive, state-of-the-art MEMS fabrication facility located near Ann Arbor, Michigan. ISSYS is currently certified for ISO 9001:2008, EN13980:2002 for its ATEX (intrinsically safe products), and ISO13485:2003 standard for Class III medical devices. ISSYS is a vertically integrated company dedicated to developing and manufacturing system-level products based on MEMS technology (MEMS Inside), please visit: http://www.mems-issys.com/
Source: Integrated Sensing Systems, Inc. (ISSYS)
Contact: Nader Najafi, Ph.D.
Integrated Sensing Systems Inc. (ISSYS)
391 Airport Industrial Dr., Ypsilanti, MI 48198
Tel: (734) 547-9896 Ext. 103
Fax: (734) 547-9964