Cath Lab Digest

Hemostatic HemCon Patch™ Selected by the Premier Healthcare Alliance as Commitment to Healthcare Quality Improvement, Innovation

The hemostatic HemCon Patch from HemCon Medical Technologies, Inc. and Cardinal Health was recently featured in the Premier healthcare alliance’s inaugural Innovation Celebration, an event to celebrate advances in healthcare while highlighting healthcare industry suppliers committed to innovation and improving patient outcomes. The HemCon Patch improves patient care following diagnostic and interventional vascular access procedures by offering safe and fast hemostasis with an effective antibacterial barrier that may help to reduce the risk of hospital-acquired infections.

Premier’s Innovation Celebration highlights innovative solutions that bring a positive impact to health care delivery. The 26 products showcased were selected by a cross-functional team of Premier alliance members and staff of varying expertise, including clinical product planners, clinical field specialists, pharmacists, supply chain professionals, materials management and nurses.

Premier contracts with more than 800 suppliers, and Cardinal Health was one of 24 selected to participate in the Innovation Celebration. Cardinal Health, the exclusive distributor and co-branded partner of the HemCon Patch™, and HemCon joined together at the event to represent the co-branded hemostatic dressings.

Innovation Celebration participants were featured on June 16 at the 2009 Premier Annual Breakthroughs Conference and Exhibition in Anaheim, Calif. Basic criteria for selection included solutions that displayed uniqueness, as well as solutions that have an impact on an unmet medical need.

For more information, please visit www.hemcon.com.

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Abbott Receives CE Mark for Company’s
Next-Generation Xience Prime™ Drug-Eluting Stent

Abbott has received CE Mark (Conformité Européenne) for its next-generation Xience Prime™ Everolimus Eluting Coronary Stent System for the treatment of coronary artery disease. The company plans to launch Xience Prime in a broad size matrix with lengths up to 38 mm in Europe in the third quarter.

Xience Prime utilizes the same drug and proven biocompatible polymer as Abbott’s Xience V® Everolimus Eluting Coronary Stent System. In addition, it offers a novel stent design and a modified delivery system designed for greater flexibility and improved deliverability. Xience Prime uses cobalt chromium technology, which allows for very thin struts while maintaining strength to support the vessel as well as excellent visibility under x-ray during the stent implantation procedure. Xience Prime is based upon the Multi-Link® family of stents. Upon launch in Europe, Xience Prime will be available in an expanded size matrix, including Xience Prime SV for small vessels and Xience Prime LL for long lesions.

Abbott’s vascular research program includes clinical trials in coronary artery disease and peripheral artery disease. Products in the vascular pipeline include: the Multi-Link 8™ Coronary Stent System, a next-generation frontline balloon dilatation catheter, a fully bioabsorbable drug-eluting coronary device, and the Omnilink Elite™ Peripheral Stent System. Additional information about Xience V is available online at www.xiencev.com

The Multi-Link 8 Coronary Stent System, the next-generation frontline balloon dilatation catheter, the fully bioabsorbable drug eluting device and the Omnilink Elite Peripheral Stent System are in development and are not available for sale.

Xience Prime currently is an investigational device in the United States and not available for sale.

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AccessClosure Launches 5 French Vascular Closure Device
Mynx M5™ Offers Patients “Artery-Friendly” Closure Solution

AccessClosure announced the newest addition to the Mynx® Vascular Closure family, the Mynx M5. The M5 is a closure device that can be delivered directly through a small 5 French (5F) cardiovascular sheath without enlarging the arterial hole or traumatizing the surrounding tissue in the process. The M5 eliminates the need for a sheath exchange, saving procedure time and expense.

“Before the Mynx M5, existing closure devices required the physician to create a larger hole in the artery just to seal it in diagnostic cases,” explains Dr. Dharmesh Patel, MD, FACC, a diagnostic cardiologist from Memphis Heart Clinic in Memphis, Tennessee. “The M5 is the first device that specifically addresses the primary clinical need for the 5F market, which is to reliably close the puncture site without enlarging it first. This is particularly useful in my practice, allowing patients to ambulate quicker with greater safety and tolerability.”

The Mynx Vascular Closure Device was first approved by the FDA for 6F and 7F cardiovascular procedures in May 2007. Since its full market release, the Mynx has been used in over 225,000 patients in over 700 hospitals nationwide. Of the Top 50 hospitals listed in US News & World Report’s “Best Hospitals: Heart & Heart Surgery,” over 75% have used the Mynx.

Like the original 6/7F Mynx device, the Mynx M5 offers patients the same important benefit – a comfortable closure experience. Many patients report that closing their artery was the most painful part of their cardiovascular procedure.

The Mynx uses a soft, bio-absorbable polymer material. This sealant material, polyethylene glycol (PEG), has been used safely for over a decade in a wide range of medical products, such as gel caps and eye drops.

During the closure procedure, the sealant is placed gently over the arterial puncture area. The sponge-like sealant immediately expands three to four times its original size by rapidly absorbing blood around the puncture site, which immediately stops the bleeding and seals the artery. The sealant then dissolves naturally within 30 days, leaving nothing behind, inside, or on top of the artery.

For more information, visit www.accessclosure.com.

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Philips Expands Emergency Healthcare Offering with Acquisition of InnerCool Therapies

Royal Philips has reached an agreement to acquire the assets of InnerCool Therapies Inc., focusing on the field of therapeutic hypothermia. InnerCool, a wholly-owned subsidiary of Cardium Therapeutics, Inc., will be acquired in an asset purchase transaction for US $11.25M, as well as the transfer of approximately US $1.5M in trade payables.

Therapeutic hypothermia solutions aim to safely induce, maintain and reverse hypothermia or maintain normal body temperature, to preserve organs such as the heart and brain in the event of sudden cardiac arrest (SCA). This rapidly-advancing technology has been recognized by the American Heart Association and the International Liaison Committee on Resuscitation as crucial in improving the survival and neurological recovery for SCA patients.

Headquartered in San Diego, California, InnerCool Therapies was founded in 1998 and will be integrated into Philips’ Clinical Care Systems business.

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Terumo Interventional Systems Announces Line Expansion of Its Pinnacle® R/O II Radiopaque Marker Introducer Sheath Products

Creates Broad Selection of Marker Band Sheath Sizes

Terumo Interventional Systems announced the expansion of its Pinnacle® R/O II Radiopaque Marker Introducer Sheaths. The Pinnacle R/O II Radiopaque Marker Introducer Sheaths are now available in 4 French through 9 French, each in 6cm, 10cm and 25cm lengths. The 10cm and 25cm are appropriate for interventional procedures (e.g. balloon and stent) or with ipsilateral approaches. The 6cm sheath can be used for superficial access sites. The 6cm and 10cm in 4 through 9 French sizes are also available with 0.038” mini guidewires (0.035” wire with 4 French sizes).

The Pinnacle R/O II lets physicians know the exact sheath tip location during a procedure. Its long gradual taper on the dilator and sheath leads to easier insertion with less force, which may result in reduced trauma and reduced complications. Additionally, the Pinnacle R/O II maintains kink resistance, which reduces the need for a second sheath.

For more information, contact Terumo Interventional Systems by calling its Inside Sales Customer Care Team at (800) 862-4143 or by visiting http://www.terumois.com.

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Vascular Solutions Launches the Trespass™ Angiographic Catheter

Vascular Solutions, Inc. announces the availability of the new Trespass™ angiographic catheter. The Trespass catheter is specifically designed for use by interventional radiologists and other physicians performing endovascular abdominal aortic aneurysm (AAA) repair procedures, and its hybrid design offers simplicity and multiple functionality.

The Trespass angiographic catheter combines an angled tip design to facilitate guidewire delivery and direction with radiopaque markers for vessel sizing and sideports for high pressure injections. Because the Trespass is a flush catheter, angled tip catheter and vessel sizing catheter all in one, it replaces multiple catheters that are commonly used in AAA procedures with just one. The catheter comes in a 5F, 65cm configuration.

The Trespass catheter is intended for use for delivering radiopaque media to selected sites of the vascular system, and for pressure and anatomical measurements, and is currently available for sale in the United States.

For more information, visit www.vascularsolutions.com.

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FDA Approves Boston Scientific’s Taxus® Liberte® Long Stent

Boston Scientific Corporation has received approval from the U.S. Food and Drug Administration (FDA) to market its Taxus® Liberte® Long Paclitaxel-Eluting Coronary Stent System, a next-generation drug-eluting stent (DES) designed for long lesions. At 38 mm, it provides doctors an option that can potentially reduce the number of stents used in more complex cases. It affords a more efficient treatment option for the estimated 8 to 10%(1) of patients with long lesions. The Company plans to launch the product in the U.S. It received CE Mark approval in 2007.

“The Taxus Liberte Long Stent offers physicians and patients distinct advantages compared to using two overlapping drug-eluting stents,” said Mark Turco, MD, FACC, FSCAI, Director of the Center for Cardiac & Vascular Research at Washington Adventist Hospital, Takoma Park, Maryland. “In the ATLAS Long Lesion Trial, the 38 mm Taxus Liberte Stent significantly reduced myocardial infarction when compared to the Taxus Express® Stent, making the Taxus Liberte Long Stent an attractive option for interventional cardiologists faced with long, challenging lesions.”

The TAXUS ATLAS Long Lesion Trial reported a significant 79% reduction in the rate of nine-month myocardial infarction for the Taxus Liberte Long Stent as compared to the Taxus Express Stent control (1.3% vs. 6.3%, p=0.026). At two years, the composite measure of cardiac death or myocardial infarction showed a significant 63% reduction for the Taxus Liberte Long Stent compared to the Taxus Express Stent (3.5% vs. 9.4%, p=0.0426). The rate of stent thrombosis at two years was zero percent for the Taxus Liberte Long Stent and 0.8 percent for the Taxus Express Stent(2).