Clinical and Industry News

Importance of FFR in Treatment of Coronary Artery Disease Confirmed by New PCI Guidelines

Level of evidence for FFR upgraded to an “A” following the recent results of the landmark FAME trial, which demonstrated that FFR-guided treatment improves clinical outcomes The American College of Cardiology (ACC)/American Heart Association (AHA)/ Society for Cardiovascular Angiography and Interventions (SCAI) guidelines upgrade the level of evidence for FFR, a physiological measure of coronary stenosis, from a “B” to an “A” because of new research conducted to determine its efficacy; the landmark FAME (Fractional Flow Reserve (FFR) vs. Angiography in Multivessel Evaluation) trial. FAME demonstrated improved outcomes for patients with multivessel coronary artery disease whose treatment was guided by FFR measurement systems rather than by standard angiography alone. The ACC/AHA/SCAI guidelines now classify FFR as “Class IIa with level of evidence A.” Level of evidence “A” is the highest level available, requiring the most clinical evidence, and is awarded only when data is derived from multiple populations and multiple randomized clinical trials or meta-analyses. The updated recommendation for FFR was issued in response to the important FAME trial data, which demonstrated many patient benefits, including a 34 percent reduced risk of combined death or myocardial infarction for those whose treatment was guided by St. Jude Medical’s PressureWire Certus™ technology prior to coronary stenting rather than angiography alone. Because data show that having physiological lesion assessment available prior to placement of coronary stents helps physicians better determine which specific lesion or lesions are responsible for a patient’s ischemia, the guidelines suggest that FFR can be useful to optimize clinical outcomes. The recommendations supported by a level of evidence “A” state that FFR can be useful in assessing whether an intervention in a coronary lesion(s) is necessary, as an alternative to noninvasive functional testing, and to help assess intermediate stenosis in patients with anginal symptoms. The FAME study was a randomized, prospective, multi-center trial which enrolled 1,005 patients with multivessel coronary artery disease. It compared outcomes for patients whose treatment was guided by FFR to those whose treatment was guided only by angiography. The 12-month results, published in the January 15, 2009 issue of the New England Journal of Medicine, demonstrated that instances of major adverse cardiovascular events (MACE), such as death, myocardial infarction or repeat revascularization, were reduced by 28 percent for patients whose treatment was guided by FFR rather than by standard angiography alone. Two-year results presented as a late-breaking trial during the 2009 Transcatheter Cardiovascular Therapeutics (TCT) meeting demonstrated that patients who received FFR-guided treatment continued to experience improved outcomes over time, including a 34 percent risk reduction of death or myocardial infarction. FFR-guided treatment was also demonstrated to be cost-saving, with a difference of about $2,000, or 14 percent, between total healthcare costs for the FFR-guided cohort and the group treated by angiography alone. These lower healthcare costs were a result of reduced procedural costs, reduced follow-up costs for major adverse cardiac events and shorter hospital stays. St. Jude Medical’s FFR Measurement System portfolio includes both the PressureWire Certus and the PressureWire Aeris™. The PressureWire Certus was the only FFR Measurement System used in the FAME trial; the PressureWire Aeris is the industry’s only wireless technology available which requires no additional equipment or cabling in the cardiac catheterization laboratory. ________________________________

Bioniche Pharma and Academic Pharmaceuticals, Inc. Announce the Introduction of Sotalol Hydrochloride Injection

Bioniche Pharma, a developer and manufacturer of injectable pharmaceuticals, and Academic Pharmaceuticals, Inc (API), a research and development company specializing in cardiovascular products, announced that Sotalol Hydrochloride (HCl) Injection for intravenous use is now available. Sotalol Hydrochloride tablets are currently available under the brand name Betapace®. Bioniche Pharma and API entered into an agreement whereby API developed and secured the FDA approval of Sotalol HCl Injection and Bioniche Pharma maintains the exclusive rights to manufacture, market, and distribute the product in the United States. Sotalol HCl Injection is currently available. Sotalol HCl Injection has a black box warning relating to life-threatening proarrhythmia. Please refer to the Bioniche Pharma website at www.bionichepharma.com for the complete prescribing information, including the boxed warning. Betapace® is a registered trademark of Bayer Schering Pharma. ________________________________

Vascular Solutions Launches the PiggyBack™ Wire Converter

Vascular Solutions, Inc. announces the availability of the new PiggyBack™ wire converter, a device designed for peripheral interventional procedures when both a 0.014” guidewire and a 0.035” guidewire are required. The PiggyBack is a 0.035” outer diameter catheter that can be delivered over and locked onto any standard 0.014” guidewire to allow subsequent delivery of intravascular devices. The PiggyBack converts the 0.014” guidewire into a 0.035” delivery device, preserving the position of the 0.014” guidewire and eliminating the need to switch out or exchange guidewires. It can either be delivered over a 0.014” guidewire that is already positioned in the vessel or preloaded onto a 0.014” guidewire before it is introduced into the body. The PiggyBack features a 0.035” outer diameter sliding lock, hydrophilic coating, a radiopaque marker band embedded in the distal tip, and is available in 80cm, 120cm, and 145cm lengths. The PiggyBack is currently available for sale in the United States via Vascular Solutions’ direct sales force. ________________________________

Toshiba Introduces New Hybrid Catheterization Table for Five-Axis Cardiovascular X-Ray Line

Toshiba America Medical Systems, Inc. has introduced the CAT-880B, a new hybrid catheterization table, for its five-axis Infinix™-i cardiovascular x-ray line. The new integrated hybrid catheterization table offers head-to-toe tilting and side-to-side cradling to meet the needs of both interventionalists and surgeons during hybrid intervention. Dr. John Cheatham, director, cardiac catheterization and interventional therapy, and Dr. Mark Galantowicz, chief, cardiothoracic surgery, both of The Heart Center of Nationwide Children’s Hospital, are recognized for pioneering the hybrid approach to treat congenital heart conditions. Both physicians worked with Toshiba engineers to design the new table and evaluated the prototype to ensure it met their needs in a real-life hybrid setting. Today, Nationwide Children’s is the first site with this hybrid catheterization table in use at its hybrid cath lab. Dr. Cheatham explains, “The table is uniquely designed to meet the individual needs of both interventionalists and surgeons. It allows them to perform the same functions used in their respective home environments — the operating room and the cath lab — together in a single hybrid suite without any sacrifice in patient access, ergonomics or efficiency.” When working on patients in a hybrid setting, it is critical the imaging system provides outstanding image quality, as well as the flexibility to reach ancillary equipment and the patient quickly and easily. The new hybrid catheterization table features a 550-pound table weight limit, making this table ideal for a range of patients, from pediatric to bariatric. It also allows for angulations of up to 16 degrees in all four directions and offers the lowest table-top height of any catheterization table in the industry. The 75-cm table height is particularly important for open surgical procedures, as it provides ultimate patient access and physician comfort, regardless of the procedure being performed. With the new table, Toshiba’s Infinix-i five-axis x-ray systems are designed to accommodate endovascular catheter based techniques, open surgical settings or a combined hybrid approach, for procedures including hypoplastic left heart syndrome and intraoperative stent therapy. The table is currently available on all five-axis Infinix-i systems and will be available for other Infinix-i configurations in the near future. For more information, visit Toshiba’s web site at www. medical.toshiba.com. ________________________________

Vascular Solutions Launches the GuideLiner™ Catheter

Vascular Solutions, Inc. announces the availability of the new GuideLiner™ catheter. The GuideLiner is a coaxial “mother and child” guide extension with rapid exchange convenience that enables deep seating, guide back-up support and selective deep intubation in challenging coronary interventions. Because the GuideLiner is a rapid exchange catheter, physicians can use standard-length guidewires, balloons or stents delivered through the existing hemostatic valve on the guide. Additionally, the GuideLiner’s soft and flexible straight tip can facilitate crossing tortuous anatomy to enable equipment delivery directly to a target lesion. The GuideLiner is compatible with standard guide catheters and is available in three sizes corresponding to 6, 7 and 8 French guides. The GuideLiner catheter is intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement and exchange of guidewires and other interventional devices. This proprietary product is currently available for sale in the United States and Europe. ________________________________

Growth Continues for Ohio State University’s Heart Program

The Ohio State University Medical Center’s Richard M. Ross Heart Hospital in Columbus, Ohio, continued its upward growth trend into 2009 with increases in patient admissions, outpatient visits and surgical procedures. In particular, significant growth continues to occur in the electrophysiology program where the number of procedures increased from 1,966 to 4,748, or 141 percent, between 2006 and 2009. Ohio State Medical Center’s Ross Heart Hospital now has one of the nation’s highest-volume ablation programs with equally high patient outcomes. In addition, despite a national downturn in catheterizations and angioplasties, the Ross Heart Hospital’s interventional cardiology program experienced a 20 percent increase in procedures between 2006 and 2009. At the same time, the heart surgery program has become a national leader for implantation of ventricular assist devices (VADs), as evidenced by a 179 percent increase in the same three-year period. The growth is attributable to transfers of extremely ill heart failure patients who benefit from the team approach to care, which includes a coordinated approach among the surgeon, electrophysiologist and heart failure specialist to achieve the best possible patient outcomes. In addition, a successful local and regional ST-segment elevation myocardial infarction (STEMI) program has reduced by half the amount of time it takes for heart attack patients arriving at OSU Medical Center to receive specialized care. The regional approach requires collaboration among the in-hospital STEMI alert team, regional emergency medical services units and the OSU emergency department. Since September 2008, STEMI patients brought to the Ross Heart Hospital have seen circulation restored in the catheterization lab an average of 28 minutes after entering the building. While the STEMI program is speeding the treatment of heart attack patients, interventional cardiology researchers and clinicians are studying the effectiveness of using non-embryonic stem cells to regenerate heart muscle and restore function. Ohio State researchers have found that “pretreating” adult stem cells with an anti-angina drug allows them to better adapt to the harsh environment of their transplantation site, in an effort to determine whether those transplanted cells eliminate or slow the tissue deterioration that would lead to heart failure. The Ross Heart Hospital is also collaborating with Arteriocyte, a biotechnology company created at Case Western Reserve University, to develop stem-cell therapies for human use. In the 2009 U.S. News & World Report magazine rankings, the Ross Heart Hospital was recognized as a leader in heart care, ranking 37 out of 4,861 hospitals from around the country. The OSU Medical Center has also been named one of the top U.S. hospitals for inpatient cardiovascular care by Thomson Reuters. ________________________________

Society Announcement

  The International Society of Advanced Level Medical Imaging Physician Specialists Inc will become known as the International Council for Certification of Cardiovascular Specialists and Assistants, Inc. on January 1, 2010. The ISMIPSI website will become www.icccsa.org on January 1, 2010.

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