SMT Research and Development completes first two clinical cases using Shimon Embolic Filter

Feb 10 2010

SMT Research and Development, Ltd., a privately held company, announced that it has completed its first two clinical cases using the Shimon Embolic Filter [SHEF] (TM). SMT R&D developed a novel technology for brain protection (Neuroprotection) from stroke complication hazards arising from invasive cardiology procedures and heart surgery. The rate of stroke and silent brain damage is the leading severe limiting factor for delivering the trans-catheter and invasive therapeutic modalities. Neuroprotection from stroke and brain emboli is a largely untapped major field. The SHEF filter reduces significantly the risk of emboli (blood clots and other debris) from traveling to the brain. The procedure was performed at the University Medical Center, Utrecht, The Netherlands by Dr. Pieter Stella, Director of Cardiac Catheterization and Interventional Cardiology.

The SMT filter is a proprietary medical device that acts as a filter, allowing normal blood flow to the brain, but filtering and diverting all emboli (blood clot, atheromatous material and calcified debris) downstream, thus preventing stroke. The product is designed to be used during interventional and surgical procedures, remaining in the patient throughout the procedure, and optionally for 24 hours, The device has a curved "snow shoe" design, with opposite stabilizers to fully fixate the device in the aortic arch. The filter is introduced in minutes through an arterial puncture and removed in the same mode. SMT R&D was established in November 2004 and is located in Herzliya, Israel. The SMT Filter device was used in a 57-year-old female patient, and a 54-year-old male patient. Both underwent repeated PCI (percutaneous coronary intervention) for treatment of instent restenosis (re-narrowing within a coronary stent). The patients had high risks of stroke complication due to paroxysmal rhythm disturbance. Rhythm disturbances increase the risk of clot formation within the left side of the heart, mainly in the left atrial appendage. These clots may dislodge and travel to the brain via the blood stream. "It is an exciting beginning of a new era for Neuroprotection. We are pleased with the overall success and ease of implementation of the SMT filter," said Dr. Dov Shimon MD, Founder and CEO, SMT Research and Development, Ltd. "

The SMT filter device was inserted through the right common femoral artery, and passed retrograde through the descending aorta and positioned along the aortic arch, in front of all arterial branches to the brain. The device maintained its position throughout the test. Subsequent passage of angiographic catheters and dye injection did not affect the position of the filter. "We were very pleased to see how easy and uneventful the procedures were." The design and engineering are user-friendly and intuitive for the cardiologist. The filter covered all the aortic arch, preventing the possibility of embolic stroke. For me and my colleagues, this is as an important adjunct as valve repairs, valve replacements and other structural heart problems that are currently treated and new modalities for treatment which are rapidly being developed. Moreover, this population of patients is sicker and increasingly older, thus the safety of the brain becomes a major issue," commented Dr. Pieter Stella.

"This is a significant milestone for SMT R&D. The engineering and scientific teams worked for 4 years to bring the filter to the clinic. It is easy and safe and to use, and is likely to provide optimum protection from stroke. These are the first and second clinical cases using our aortic embolic protection device designed for interventional procedures. A feasibility study is underway in Europe, in The Netherlands and Germany, to be followed in other countries, added Dr. Dov Shimon.