Despite the past few years’ product recalls and safety controversies, The Freedonia Group, Inc. estimates the demand for implantable devices will increase 9.3% annually in the US. Sales will reach $43.6 billion in 2011.

Driving the increased demand are shortcomings in existing drug therapies. In their place is a resurgence of cardiac and orthopedic implants; estimated to grow in demand at 9% and 8.8%, respectively. Cardiac implants represent the top seller of implantable medical devices, due to the prevalence of heart disease in the United States, and the extremely life-threatening nature of the disease itself.

Abiomed Inc. has received FDA approval, under special humanitarian device exemption, for system upgrades to its AbioCor implantable artificial heart. The device replaces severely damaged hearts for patients who are not eligible for a transplant or alternative treatment. The approval restricts the device from being sold to more than 4,000 patients in the U.S. per year. The company expects to charge $250,000 per AbioCor unit.

The FDA Humanitarian Device Exemption (HDE) is an application that is similar to the FDA premarket approval (PMA) application. An HDE is granted for an HUD (Humanitarian Use Device), which, according to the FDA, is a:

“Medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year.”

St. Jude Medical Inc. has received FDA approval for software and firmware updates to its Internet-based data management system for implantable cardiac devices. The Merlin.net PCN (Patient Care Network) will now enable doctors to remotely monitor patients nationwide, who send data via phone lines. The updated version also allows patients with these implantable cardiac devices to transmit data from outside the U.S.

Merck & Co. and Schering-Plough Corp. are running newspaper ads to protect the reputation of the cholesterol-lowering Vytorin drug, after having announced disappointing results last week. The latest ENHANCE study, which aimed at measuring Vytorin’s ability to reduce clogged arteries, showed the drug to be only minimally more effective than a generic statin. Cardiologists are now questioning the use of Vytorin, which combines Zetia and Zocor (or simvastatin) into one pill.

The ENHANCE study was only an initial study and was not as thorough as clinical trials.

Merit Medical Systems, Inc. has received FDA approval for its new Sea Dragon torque device. The device is used specifically with hydrophilic guide wires. It was recently released in Europe. The company plans to release the Sea Dragon product in the U.S. in January 2008.

Full story here.

Lumedx has released CardioManager Performance Management System, software that turns complex clinical, operational and financial data into usable information. Among other things, the software will help manage all of the work across the cardiovascular team, as well as facilitating team collaboration and delivering more than 200 standard reports. The new CardioManager product integrates witht he companies CardioStar suite of cardiovascular information and imaging tools.

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Cardica Inc. has announced that it will webcast a live off-pump coronary artery bypass graft (CABG) procedure. Doctors will perform the beating heart procedure using Cardica’s C-Port(R) xA and C-Port(R) Flex A Distal Anastomosis Systems, which are designed to allow surgeons to automate the attachment of blood vessel grafts, replacing the process of hand-sewing with sutures.

The procedure and live webcast will take place on January 17, 2008 at 3pm EST. The recorded event will be available to watch following the procedure on ORlive.com.

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