Medtronic announces first implant of fourth generation heart failure device

Meditronic, Inc. announced the first implant of the InSync Marquis system, the company’s fourth generation heart failure device and its second to treat patients who also need the protection of an implantable defibrillator. The InSync Marquits – like the InSync ICD that is currently in review by the US Food and Drug Administration – provides cardiac resynchronization therapy (CRT) plus advanced defibrillation capabilities for patients at risk of potentially lethal tachyarrhythmias that may lead to sudden cardiac arrest.

The InSync Marquis device combines the cardiac resynchronization therapy of Medtronic’s InSync ICD, the heart failure diagnostics of InSync (R) III, and all of the advanced features of Medtronic’s Marquis DR implantable cardiovetter-defibrillator. The Marquis DR ICD received FDA approval March 1, 2002, while the InSync III device is commercially released outside the United States.

The InSync ICD system was recommended for approval by an advisory panel of the FDA on March 5, 2002. The InSync Marquis was implanted in a 65 year old man by Dr. Thomas Schqierz at the Krankenhaus der Elisabethinen clinic in Linz, Austria, under the direction of heart failure specialist Dr Siegmund Winter. The patient had received a Medtronic Microjewel defibrillator in 1996 to treat ventricular arrhythmias resulting from a previous myocardial infarction and coronary artery disease. Over the last several years, he gradually developed progressive heart failure.

"The InSync Marquis system gives me confidence that my heart failure patients are well treated," said Dr. Winter. "The high defibrillation output and heart failure diagnostics are especially important for patients with this condition."

American Pharma launches first needless, heparin-filled plastic ampule

American Pharmaceutical Partners announced it has launched SmartAmp, the first needless, all-plastic ampule containaing heparin, an anticoagulant used in the treatment of a variety of medical conditions and commonly administered through vascular access devices.

Patrick Soon-Shiong, MD, chairman, president and chief executive officer of American Pharmaceutical Partners (APP), said, "The introduction of SmartAmp with heparin is in keeping with our commitment to develop innovative products that improve the safety of administering pharmaceutical compounds and meet unmet medical needs. We believe that SmartAmp and other such delivery systems will become important components of our future product offerings."

"We think the medical community will embrace this product for several important reasons," said Jeffrey Yordon, chief operating officer of APP. "SmartAmp is simple to use, therefore it should reduce the number of steps involved in administering medications and it may lower a healthcare provider’s exposure to dangerous needlesticks. It also provides a cost-effective packaging alternative to currently available heparin products."

Yordon noted that heparin represents one of APP’s top ten selling products. The use of SmartAmp involves simply twisting off the top of the latex-free, shatterproof ampule, attaching it to a syringe, pulling back on the plunger and removing and disposing of the SmartAmp once the heparin fills the syringe. Unlike the traditional syringe method, SmartAmp does not have glass, needles, or sharp bands than can cause injuries to medical staff and patients.

SmartAmp was developed in accordance with the Occupational Safety and Health Administration’s (OSHA) recently revised blood borne pathogens standard as mandated by the Needlestick Safety and Prevention Act. This act directs employees to select safer needle devices as they become available. American Pharmaceutical Partners, Inc. is a specialty drug company that develops, manufactures and markets injectable pharmaceutical products, focusing on the oncology, anti-infective and critical care markets.