St. Jude Assura Heart Devices Receive European Approval

St. Jude Medical received CE mark approval for the Assura portfolio of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). The Assura family of devices has three new algorithms that, according to the company, help protect patients against inappropriate shocks while providing the highest amount of delivered energy. These improvements are projected by St. Jude to reduce inappropriate therapy by 74 percent, allowing for more effective therapy. Products currently available in Europe include the Quadra Assura CRT-D, Unify Assura CRT-D and Fortify Assura ICD.

ICDs are implantable cardiac devices that treat abnormally fast, potentially lethal heart rhythms that can lead to sudden cardiac death if left untreated. A CRT-D device resynchronizes the beat of the heart’s lower chambers, which often beat out of sync in heart failure patients. A CRT-D also provides back up treatment for SCD, which is a risk factor associated with certain types of heart failure.

According to St. Jude, all Assura devices can produce 40 Joules of energy. The devices include expanded ShockGuard technology for protection against inappropriate and unnecessary shocks, CorVue congestion monitoring and algorithms including SecureSense RV lead noise discrimination, which reportedly offers physicians advanced alerts and helps proactively lower the risk of lead-related complications by automatically withholding tachycardia therapy in the presence of lead noise (an over-sensing of electrical signals).

The Fortify Assura device also offers enhanced ST segment monitoring (which tracks electrical changes between heartbeats). Monitoring of the ST segment helps indicate conditions such as ischemia, which happens when blood flow and oxygen to the heart muscle is obstructed. ST segment monitoring in an ICD prior to therapy for ventricular arrhythmias can offer greater insight into the cause of these dangerous heart rhythms.

“With the three new discriminators and highest amount of delivered energy, the Assura devices provide the ideal combination of intelligence and strength. These devices offer unique features that I believe will help protect my patients from inappropriate shocks and provide greater defibrillation therapy assurance,” said Klaus-Jürgen Gutleben, M.D., of the Heart and Diabetes Center North Rhine-Westphalia in Bad Oeynhausen, Germany.

The Quadra Assura CRT-D is the company’s first device with quadripolar pacing technology on the market. It is designed to address common pacing complications such as phrenic nerve stimulation and high pacing thresholds, which can result in fewer surgical revisions, shorter procedure times and decreased fluoroscopic exposure. The Unify device is a second-generation version of its predecessors. It differs from Quadra in that it is not quadripolar, but according to St. Jude it has a very small footprint for a reduced incision size. The Fortify Assura ICD offers ST monitoring and, according to the company, provides the highest delivered energy of any ICD on the market.

“St. Jude Medical understands patients’ needs vary, which is why we are excited to add three new defibrillation technologies in Europe to our complete portfolio of cardiac rhythm management devices,” said Eric S. Fain, M.D., president of the St. Jude Medical Implantable Electronic Systems Division. “The Assura line of devices was designed for safety, reliability and extended longevity to help physicians best treat their patients.”

St. Jude Medical is the second largest producer of cardiac technology next to Medtronic Inc., but has been under the microscope in recent months due to controversy over its Riata and Durata defibrillator lead wires. In the aftermath of questions surrounding the products’ safety, the board of directors have approved a plan for a share buyback program for as much as $1 billion.

The repurchase is a move toward reinstating confidence in the company, said the company board of directors. “The share repurchase program demonstrates the confidence our board and management team have in the long-term prospects for St. Jude Medical,” said Daniel J. Starks, president and CEO of St. Jude. “We remain committed to delivering superior results and value to our shareholders.”

The repurchases will be staggered, occurring strategically when the company deems a purchase to be most effective, either in private negotiated transactions or otherwise. As of Nov. 28, the company had approximately 308 million shares of common stock issued and outstanding. St. Jude expects to fund this program with cash on hand as well as other sources of available liquidity.

St. Jude Medical provides technology in the cardiac rhythm management, atrial fibrillation, cardiovascular, and neuromodulation spaces.