March 22, 2007 — St. Jude Medical Inc. says it has received FDA approval of a new cardiac rhythm management device designed to help physicians manage heart failure (HF) patients, including patients who have or may develop atrial fibrillation (AF).

March 22, 2007 — McKesson has announced it has expanded its distribution agreement with Toshiba America Medical
Systems, Inc., to include cardiovascular medical solutions. Nine months ago the two companies had announced their initial radiology imaging partnership, which has been a success, they say.

The Human Patient Simulator (HPS) – a computer-model-driven, full-sized mannequin – delivers experience in true-to-life scenarios that swiftly change to meet instructors’ goals. The sophisticated and versatile HPS blinks, speaks and breathes, has a heartbeat and a pulse, and accurately mirrors human responses to such procedures as CPR, intravenous medication, intubation, ventilation and catheterization.

Procedicus VIST is a simulator for catheter-based procedures providing relevant and realistic hands-on training for angiography and interventional procedures at different levels.

The system is a multidisciplinary platform enabling the user to practice carotid, coronary, iliac/SFA, neuro, renal, electrophysiology and pacing procedures with the same clinical devices used in procedures with live patients. It allows the user to try different devices and evaluate approaches to procedures in a safe environment. Real patient data is used to generate the simulated patient cases.

The 023 version of Vascular Solutions’ Twin-Pass dual access catheter features a larger 0.023-inch lumen that allows it to measure intra-arterial pressures and deliver specialty guidewires into the distal vasculature.

The original Twin-Pass catheter was launched in January 2006 as a two-lumen catheter designed to be used in conjunction with steerable guidewires to access discrete regions of the coronary and peripheral arterial vasculature.

The Pinnacle R/O II HiFlo Introducer Sheath is a 4-cm stiff introducer sheath that features a smooth transition that facilitates access to difficult superficial sites, which may also be close to the location of a lesion. In addition, a larger diameter side flow tube allows a higher flow rate of fluids.

The system also features a radiopaque marker band 5mm from the tip for enhanced visibility, a laminar flow sheath housing with a side tube take-off to improve flow dynamics and a detachable 3-way stop cock.

A new ablation catheter designed to give physicians improved range of motion and ease of use during procedures to eliminate abnormal heart rhythms, the EZ Steer Bi-Directional Catheter helps physicians restore atrial tachycardias into normal sinus rhythm. This enables the heart to efficiently pump blood to the body's vital organs. The defining feature of this product is its micro-tensioning system, which allows physicians — through a series of very small, continuous micro-movements — to progressively dial in the precise force desired for deflection of the catheter.

The intra-aortic balloon (IAB) is an minimally invasive technology designed to enhance blood flow to the heart and other organs for patients with diminished heart function.

During FDA testing, the new balloon was subject to extensive reliability testing and successfully demonstrated a life of over eight million cycles, which equates to more than 90 days of continuous operation. The 8F IAB is inserted percutaneously into a patient’s descending aorta and inflates and deflates in counterpulsation to a patient’s heart rhythm.

The Vanguard Dx Angiographic Catheter with patented RadiantFlow tip technology delivers contrast in a unique way. Vanguard Dx produces a “cloud” of contrast rather than a jet stream like traditional catheters. This cloud-like dispersion helps to reduce catheter whipping and enhance tip stability. The catheters are available in the 15 most common shapes and in 4F and 5F sizes.

Enabling radiologists to diagnose images generated by noninvasive cardiac scanning methods, several specialized functions — cardiac review and analysis, cardiac cage removal in 3-D imaging and cardiac calcium scoring — are being integrated into the newest version of Kodak Carestream PACS Software.

Cardiac review and analysis provides four-chamber and cross-sectional views of the heart axis and panoramic and cross-sectional views of cardiac vessels such as the left main artery (LMA), right coronary artery (RCA), left circumflex artery (LCX) and posterior descending artery.

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