March 22, 2007 — Edwards Lifesciences Corp. says it has received conditional FDA approval to initiate a pivotal clinical trial of the SAPIEN transcatheter aortic heart valve technology. The PARTNER (Placement of AoRTic traNscathetER valves) trial will evaluate the SAPIEN valve in patients who are considered high risk for conventional open-heart valve surgery.

March 22, 2007 — Evalve, Inc., a privately held medical device company, has announced the FDA has approved a registry of up to 70 patients who are at high risk of mortality from surgical treatment for mitral regurgitation (MR) as part of its ongoing pivotal EVEREST Study (Endovascular Valve Edge-to-Edge REpair STudy).

March 22, 2007 — MedicalCV Inc. has announced it has received FDA clearance for its SOLAR Surgical Ablation System for the ablation of soft tissue. The company developed the SOLAR System to enable automated, computer-controlled ablation in surgical procedures utilizing laser energy.

MedicalCV Inc. is a medical device company that develops, manufactures and sells surgical ablation systems that utilize a laser energy technology platform to create precise lesions, or scars, on soft and cardiac tissues. The Company's core technologies are the SOLAR and ATRILAZE

March 22, 2007 — Pfizer says the FDA has approved the company’s Lipitor (atorvastatin calcium) Tablets to reduce the risk of nonfatal heart attacks, fatal and non-fatal strokes, certain types of heart surgery, hospitalization for heart failure, and chest pain in patients with heart disease — making Lipitor the first cholesterol-lowering medication to receive FDA approval for the reduction of the risk of hospitalization for heart failure.

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.

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