Mar-08

Bayer HealthCare affiliate MEDRAD, Inc., of Warrendale, PA and Possis Medical, Inc., of Minneapolis, MN, have entered into a definitive merger agreement pursuant to which MEDRAD will acquire Possis Medical in a cash tender offer for US$19.50 per share, or a total equity value of approximately US$361 million. The offer price represents a premium of approximately 39 percent over Possis Medical’s average closing price for the thirty days prior to February 8, 2008. The board of directors of Possis Medical has unanimously approved the transaction and resolved to recommend the offer to their shareholders.
MEDRAD is a provider of contrast injection systems used to diagnose cardiovascular and other diseases. Possis Medical is a provider of mechanical thrombectomy devices used to treat narrowed or blocked arteries and veins.
Possis Medical posted revenues of $67 million and employed approximately 280 people for its fiscal year ending July 31, 2007. Premiering in 1997, Possis Medical’s AngioJet^® Rheolytic^™ Thrombectomy System is a mechanical thrombectomy system with FDA approval to remove large and small thrombus from coronary arteries, coronary bypass grafts, peripheral arteries and veins, A-V grafts and native fistulas. Possis Medical recently launched the AngioJet Ultra System, a new easier-to-use drive unit.
Used in diagnostic imaging, MEDRAD’s product offerings include a comprehensive line of vascular injection systems, magnetic resonance (MR) surface coils and patient care products, and equipment services. Total 2006 revenues were US$478 million. MEDRAD is an affiliate of Bayer AG and employs over 1,700.

Growing Mobile Cath Lab Market Leads to Expansion at Modular Devices Inc.

Move to larger production facility will allow company to keep up with the growing demand for nobile and modular cardiac/vascular & EP lab rentals. Continuing to deliver upon its commitment to growth and innovation, mobile cath lab industry founder Modular Devices Inc. has moved into a new corporate office and production facility to meet the demands of a growing industry. The new corporate office is a completely remodeled 75,000-square-foot facility located at 6678 Guion Road, Indianapolis, Indiana, which will house all of the administrative, production, and engineering functions of the company in one central location. The company had previously operated out of a 15,000 square foot facility in Carmel, Indiana. The move into the larger facility will allow Modular Devices Inc. to expand into other growth areas supporting cardiology, electrophysiology, interventional, vascular and pediatric programs.
“Our company has experienced phenomenal growth over the last 4 years,” says Greg Mink, CEO of Modular Devices Inc. “This new facility finally allows us room to not only meet the current demand, but also the strong market demand we forecast into the foreseeable future.”
In 1987, Modular Devices Inc. founded the mobile cath lab industry. Modular Devices Inc. operates not only the largest selection of mobile labs for lease, but also offers an industry-exclusive modular lab design for customers who require a larger lab with easier access, especially designed for longer term leases and start-up programs.

GE Healthcare Works with Experts to Develop a Cardiac Vital Signs Educational Program for Clinicians

GE Healthcare announced a new addition to their growing portfolio of continuing education offerings. “New Cardiac Vital Sign: Assess and Manage Stroke Volume” is an interactive program for clinicians on monitoring and managing stroke volume, which is becoming recognized as the “new cardiac vital sign” for assessing patient status.
The online course is designed to help clinicians enhance patient care where non-invasive and invasive technologies are used, such as the ED, ICU, OB, Pediatrics, Telemetry, PACU, Pre-hospital, Cath labs, Cardiac Care, MICU and SICU.
Clinicians can use stroke volume measurement as a tool to help them assess and proactively manage patients. Building on a solid foundation of evidence-based medicine and the results of research done with non-invasive and invasive technologies, noted critical care and hemodynamic monitoring experts and founders of the ICU-USA online learning platform, Thomas Ahrens, DNS, RN, CCNS, FAAN and Robert Taylor, MD, FCCM, FCCP present dynamic, interactive courses addressing significant patient care issues.
This self-paced program models actual clinical applications and outcomes, giving the clinician an interactive learning experience, such as allowing clinicians to enter a “virtual” hospital to assess and treat patients. The course uses “virtual reality” patient rooms supplemented with a comprehensive “virtual library” to aid clinicians in researching their clinical decisions.
Ahrens and Taylor provide a look at patient care from the perspective of nurses and physicians.
Taylor said, “Many clinicians do not fully understand the fundamental concepts of hemodynamic monitoring and, often, experts disagree on therapeutic strategies for hemodynamic profiles.”
Aherns said, “With cardiac output and stroke volume providing such excellent information on patient status, managing hemodynamics becomes important to any clinician, from pre-hospital to pharmacy, critical care and beyond, even to sleep centers. For the first time, almost any pediatric or adult patient can be monitored in any clinical setting.”
Ahrens continued, “Stroke volume, peak velocity and flow time are among the hemodynamic parameters describing biological signals indicative of the cardiovascular system and its function. The objective is to recognize early indicators of a hemodynamic crisis and proactively manage before a significant and dangerous event occurs. Applying these principles can minimize patient risk, and allow a wider population to be monitored, thus optimizing patient care. Cost reductions are also a benefit as non-invasive monitoring techniques are less expensive than invasive monitoring procedures, incur less risk, and can positively impact length of stay.” GE’s website provides more information on the “New Cardiac Vital Sign: Assess and Manage Stroke Volume” course at: www.gehealthcare. com/clinicaled.

The International Society of Advanced Level Medical Imaging Physician Specialists Has Begun

The following professionals are eligible to become members of the International Society of Advanced Level Physician Specialists:
1. Any nurse practitioner, physician assistant, radiology practitioner assistant, radiologist assistant, sonographer or radiologic technologist who works in cardiovascular settings such as invasive-interventional cardiology and interventional radiology;
2. Registered cardiovascular invasive specialists (RCISs);
3. Persons qualified to take the Cardiac Interventional and/or the Vascular-Interventional advance examination with the ARRT;
4. Persons qualified to take the advanced-level RCIS examination;
5. Sonographers who are going to take the ARDMS and/or ARRT sonography examinations. To find out more information and/or become a member, please contact Ms. Pattie Freschett at pattief99@yahoo.com.

Terumo Launches the new AZUR^™ Peripheral HydroCoil^® Embolization System with Expanding Hydrogel Technology

Terumo Interventional Systems announces the launch of the AZUR Peripheral HydroCoil Embolization System for the occlusion of blood vessels, vascular malformations, and aneurysms. AZUR is a peripheral platinum coil embolization system with a hydrogel coating that expands when introduced into the bloodstream, delivering greater filling and mechanical occlusion — all with fewer coils.
AZUR’s hydrogel coating undergoes limited expansion within the first 3 minutes, and fully expands within 20 minutes. The result is greater filling and mechanical stability with fewer coils—nearly 5 times more filling volume for the 0.018” coil and 4 times more filling volume for the 0.035” coil (versus platinum coils of the same size).
In addition to its unique HydroCoil technology, AZUR is the only peripheral embolization system to offer a truly detachable system, giving physicians the ability to detach coils in less than a second and at the push of a button. With the capability to withdraw and reposition the coil until the coil is securely placed, the system minimizes the risk of non-target embolization and coil migration. This offers a whole new level of control, making it ideal for high-flow areas and challenging vascular anatomy.
Dr. Craig Greben, Chief of the Division of Interventional Radiology at the North Shore University Hospital on Long Island in New York, was the first physician to successfully use the AZUR Peripheral HydroCoil Embolization System in his practice. Deploying AZUR in a patient who had 2 large splenic artery aneurysms, Dr. Greben reported that AZUR filled the aneurysm with precision and ease and required fewer coils. For more information, customers can contact Terumo Interventional Systems by calling its Inside Sales Customer Care Team at 800-862-4143 or by visiting https://www.terumois.com.

Medtronic Receives FDA Approval for Endeavor Zotarolimus-Eluting Coronary Stent System
Medtronic, Inc., has received approval from the U.S. Food and Drug Administration (FDA) for the Endeavor® Zotarolimus-Eluting Coronary Stent System to be used in the treatment of coronary artery disease. The Endeavor data encompasses the largest, most wide-ranging patient population submitted to the FDA in support of a drug-eluting stent, including more than 4,100 patients, followed up for as long as four years. This extensive clinical research has shown that Endeavor provides a consistent and sustained reduction in the need for repeat procedures compared to a bare-metal stent, while also maintaining an excellent safety profile. The Endeavor stent is the first new drug-eluting stent approved by the FDA since 2004.
“Endeavor represents a true next-generation drug-eluting stent because of its unique design, which combines an advanced stent platform with the potent drug zotarolimus and a biocompatible polymer,” said Dr. Martin B. Leon, professor of medicine at Columbia University Medical Center in New York, cardiologist at New York-Presbyterian Hospital/Columbia University Medical Center, founder and chairman emeritus of the Cardiovascular Research Foundation, and principal investigator of the ENDEAVOR III and IV clinical trials. “This device addresses an important need by demonstrating comparable clinical effectiveness to a first generation drug-eluting stent while also exhibiting a safety profile more typical of a bare-metal stent, long considered a benchmark for safety performance. In addition, it has the advantage of being exceptionally easy to deliver through the tortuous vessels of the coronary vasculature.”
Ultimately, the ENDEAVOR clinical program will enroll more than 22,500 patients followed to five years; approximately 16,630 of these patients will receive an Endeavor stent.
As a condition of FDA approval, Medtronic will continue its extensive post-market clinical program, which will now add sites in the United States to ensure that at least 5,000 patients are followed to a minimum of five years. In addition, Medtronic will collaborate with the FDA to conduct or participate in a study intended to identify the optimal duration of dual anti-platelet therapy following percutaneous intervention with the Endeavor drug-eluting stent. More information for physicians and patients is available online at www.EndeavorStent.com.

Medical Simulation Corporation and the American Board of Internal Medicine Introduce New Simulation for Physician Assessment and Evaluation
The American Board of Internal Medicine (ABIM) will offer Interventional Cardiology Simulations, using Medical Simulation Corporation’s (MSC) SimSuite^® technology, for credit toward completion of Maintenance of Certification. This is the first time ABIM is incorporating medical simulation technology into its programs to evaluate physician competence.
SimSuite technology replicates a real-life catheterization lab, and the five case scenarios developed by ABIM mirror what an interventional cardiologist would typically face in daily practice. Completion of Interventional Cardiology Simulations will provide physicians with 20 points toward completion of the Self-Evaluation of Medical Knowledge requirement for Maintenance of Certification. It will be offered at MSC’s SimSuite education centers and several professional conferences.
“MSC is excited to work with ABIM to use simulation as an assessment tool,” says Bill Younkes, MSC president and CEO. “ABIM is demonstrating great leadership in offering this innovative option to internists involved in Maintenance of Certification.”
MSC began working with ABIM in 2003 to investigate the potential of using simulation technology as an evaluation tool. Ten clinical centers participated in the study, in which 120 physicians with varying levels of expertise completed six cases. Study results indicated that the simulated cases could assess cognitive and procedural skills in performing interventional cardiology procedures, and could discriminate between novice and advanced skill levels of physicians performing interventional cardiology procedures.
Visit ABIM at www.abim.org for more information. Physicians enrolled in Maintenance of Certification can register online for the simulation, which is available at six MSC SimSuite education centers nationwide and several national conferences.

Medical Ventures to Acquire Two Vascular Device Developers
Medical Ventures Corp., specializing in products for the vascular and surgical markets, has signed an agreement to acquire two vascular product development companies. The two acquisitions are B-Balloon Ltd. and Neovasc Medical Ltd., both early-stage life sciences companies incubated by Israel-based Peregrine Ventures. Each company is focused on developing new technologies for the interventional treatment of heart and vascular diseases. Neovasc has developed a specialized stent for the treatment of refractory angina, and B-Balloon is developing devices used to treat ostial and bifurcation lesions in coronary and peripheral arteries.
Medical Ventures’ head office will remain in Canada, while Neovasc and B-Balloon’s product development activities will continue in Israel. Medical Ventures’ surgical tissue and contract manufacturing business will continue to operate within the company’s existing PM Devices division.
For more information, please visit: www.medical-ventures.com.