Nuth, February 2008, TopSpin Medical, Inc. announces first commercial installation of the Cathamaran(TM) Intravascular MRI System at ZOL Hospital, Genk, Belgium, with the first procedures performed on January 16th.

"We are pleased to be the first site to install the Cathamaran(TM) IVMRI System. This 6F compatible technology represents a major breakthrough in our ability to detect and quantify lipid present in coronary lesions. We are very excited to be among the first centers to participate in the MIRACLE Study to further evaluate the clinical role for IVMRI in both diagnostic and interventional coronary catheterization procedures. The identification of high risk, lipid -rich lesions that may be prone to rupture is of paramount importance, and the IVMRI System may potentially help address this unmet need," stated Dr. M. Vrolix from ZOL hospital, Belgium.

The company and distributor TOP Medical are currently in advance negotiation for similar agreements with additional medical centers in the Benelux territory. The company is expecting to install additional Cathamaran(TM) Intravascular MRI systems in the Benelux territory in the course of the current quarter.

The Cathamaran(TM) IVMRI System will be used in a post-market Study of coronary plaque lipid characterization by IVMRI performed during diagnostic or interventional catheterization [MIRACLE Study]. The multi-national prospective MIRACLE Study is designed to collect data on a widespread post-market clinical experience to evaluate how lipid quantification with the IVMRI System may be used to guide patient treatment.

Yaron Tal, President and Chief Executive Officer of TopSpin Medical, said: "The introduction of our unique Cathamaran(TM) Intravascular MRI System and the initiation of the MIRACLE Registry represent major milestones for our company. We are committed to advancing investigation into vulnerable plaque with the goal of improving diagnosis of these high-risk lesions and aiding development of appropriate therapeutic solutions. We are very excited to collaborate with ZOL hospital in this important investigation."

Nuth, February 2008; TOP Medical launches the Merci L4 and Merci L6 Retrievers®  from Concentric Medical for use in Stroke Patients.

These new Retrievers, released in the United States in 2007, join the existing Merci Retrievers® already on the market in Europe, and provide physicians with additional choices in their efforts to restore blood flow in ischemic stroke patients.

The Merci L4 and L6 Retrievers join Concentric Medical’s L family of Retrievers which incorporate filaments into the retrieval helix. These filaments provide an additional mechanism for securing blood clots during retrieval from the brain. The Merci L6 Retriever has a 2.7 mm cylindrical helix and is designed for use in larger vessels than the Merci Retrievers currently on the European market. The Merci L4 Retriever has a 2.0 mm cylindrical helix and is designed for use in smaller vessels, further adding to the Merci Retriever portfolio. 

"The Merci Retrieval System™ has been used on many more ischemic stroke patients than any other clot retrieval system, and we continue to incorporate the knowledge gained from this experience into improved devices,” said Gary Curtis, President and CEO of Concentric Medical. "These next generation Retrievers are further evidence of our leadership in bringing exciting and new life saving options to stroke patients.”

The Merci Retriever is a shaped wire constructed of nitinol, a “memory wire,” that allows delivery of the Retriever in linear form using standard catheterization techniques. A small puncture in the groin is used to introduce the Merci Retriever into an artery leading to the brain. Upon reaching the targeted area, the Merci Retriever is deployed and returns to its original helical shape. The Merci Retriever is designed to restore blood flow by engaging, capturing and removing blood clots.

Nuth, October 2007: TopSpin Medical (TASE: TOPMD) announced that the 30-day results from the multicenter prospective study of the TopSpin Intravascular Magnetic Resonance Imaging System During Coronary Endovascular Catheterization (TOPIMAGE) demonstrated the safety and technical procedure success for the IntraVascular MRI (IVMRI) catheter in the coronary arteries. The study enrolled a total of 104 patients contributed from 10 centers in the US, Europe and Israel. Martin Leon, MD, of Columbia University Medical Center, New York, NY, and Co-Principal Investigator of the TOPIMAGE study, presented the study results at the Transcatheter Cardiovascular Therapeutics (TCT) 2007 Scientific Symposium in Washington DC. 

“This study showed that the novel self-contained IVMRI system is feasible for use in the cardiac catheterization lab setting. We are pleased with the clinical results to-date, and we are enthusiastic to expand the clinical evaluation of the System,” said William Wijns, MD, of Onze-Lieve-Vrouw Hospital, Aalst, Belgium, and Co-Principal Investigator of the Study.

The Company also announced that it has recently submitted a 510K application to the US FDA, which included the compiled TOPIMAGE results, as a required step toward obtaining marketing clearance for its IVMRI System in the US.

“Completion of the TOPIMAGE study and submission of 510K marketing application are major milestones for the Company and represent the culmination of several years of research and development. We believe that IVMRI will become a very beneficial diagnostic tool for early detection and guidance of treatment for high risk coronary plaques,” said Yaron Tal, CEO of TopSpin Medical.

The TOPIMAGE study was designed to assess device safety and functional performance of the IVMRI System in patients undergoing cardiac catheterization. The primary endpoint of the study was the incidence of major adverse cardiac events (MACE) at 24 hours. The incidence of MACE at 24 hours was only 0.96% (1 patient), and at 30 days was 1.9% (1 additional patient). There were no deaths and no perforations. Performance success was achieved in 88%, and at least one IVMRI measurement was obtained in 95% of patients.

Rupture of coronary plaque with subsequent thrombus (blood clot) formation is the underlying cause of most acute coronary syndromes (ACS). Early reliable assessment of lipid- rich vulnerable plaques near the surface of the arterial wall may lead to more aggressive treatment of coronary artery disease and reduce the overall incidence of myocardial infarction (heart attack) and death. TopSpin’s IVMRI catheter is the first device designed for percutaneous intravascular imaging and characterization of the tissue lipid composition of coronary plaque during a conventional cardiac catheterization procedure. The IVMRI catheter is designed to measure the lipid content within the target plaque.

Nuth, September 2007: Concentric Medical is a medical device company that designs, develops and markets products for restoring blood flow in patients who have suffered ischemic strokes, which result from blood clots in the vessels of the brain. The Merci Retrieval System is designed to restore blood flow in the neurovasculature of ischemic stroke patients by removing blood clots. In 2004, it received clearance from the U.S. Food and Drug Administration, or FDA, for this indication, and the system is the only such FDA cleared device. It has also received FDA clearance to market the device for use in the retrieval of foreign bodies misplaced during the interventional radiological procedures in the neuro, peripheral and coronary vasculature. We believe that the Merci Retrieval System offers an option for ischemic stroke patients, who historically have had few other treatment options available. We estimate that over 6,000 patients have been treated to date with the Merci Retrieval System. Within the Netherlands there are sofar 4 hospitals equiped with this technology.

Nuth, September 2007: TOP Medical launced at the Cirse in Athens the Scuba Cobalt Chromium Peripheral Stent from Invatec. The Scuba is the first Cobalt Chromium Peripheral Stent System with unlimited deliverability and flexibility, even in contralateral approaches. The closed and diameter specific cell design enable a predictable scaffolding and appropriate radial force.

Nuth, August 2007: Over the last years TOP Medical supported start-up as well as corporate companies with their European clinical activities. Recently we decided to establish an independent division for these Clinical Trial Services managed by Annemieke van de Weyer. Within this division we assists our partners in all stages of the clinical trial process as site selection, submission to ethics committees, study initiations, clinical & technical support, monitoring, device accountabilitsy and logistics.
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Nuth, June 2007: The Relay Thoracic Stent-Graft & Transport Delivery System is the next generation stent-graft specifically designed for aortic arch applications and long-term deliverability. The Freeflex Technology creates independent articulation of the primary sealing & fixation zone, allowing it to orientate itself independently of the secondary sealing & fixation zone and the rest of the stent graft. This feature provides safe and secure fixation and sealing plus 3Dimensional conformance. The spiral support strut is the perfect balance of multi-directional flexibility and column strength. Acting as a shock absorber, the spiral support strut absorbs the natural forces with the aorta eliminating a focal stress point.

Nuth, October 2006: TopSpin Medical has developed an IntraVascular MRI (IVMRI) catheter for local high-resolution MR imaging of the coronary arteries, which incorporates all magnetic field sources and eliminates the need for external magnets and a bulky and expensive MRI scanner. TopSpin's IVMRI catheter will potentially enable interventional cardiologists to guide therapy to vulnerable plaques.

Nuth, May 2006: CathRX is a specialized Australian medical devices company initially focusing on the development and commercialization of a range of innovative cardiac catheters for use in the diagnosis and treatment of electrical problems of the heart known as cardiac arrhythmias.

Nuth, January 2006: Due to excellent characteristics of the Co-Cr stent material, the SKYLOR cobalt-chrome coronary stent combines good visibility, thin struts, minimal passage profile and high radial strength. The newly designed RX-segment with an adjusted nitinol wire enables an optimal passage from a high pushability of the hyper tube shaft to the complete flexibility of the distal catheter. The new balloon material FLEXITEC™ Ultra of the stent delivery system assures highest flexibility and a low passage profile with semi compliance. The struts, 80 micron thin, contribute to an ultra thin passage profile for a safe success in an ambitious anatomy. The closed cell design offers a stable, reliable and permanent homogeneous scaffolding, no matter what kind and curve of the lesion. The Tight-Fix™ crimping technology enables a secure stent fixation to the balloon, even at difficult passages in curved anatomy.