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Heart Failure: Next-Gen VADs Fuel Optimism Amid Challenges

Executive Summary

Although near-term challenges have slowed growth in the market for left ventricular assist devices (LVADs), companies are developing new, less invasive VADs with improved pump designs to further improve patient outcomes and allow for a wider application of the therapy in treating heart failure. These next-generation VADs are fueling long-term optimism in the market for mechanical circulatory support, which remains one of the more attractive opportunities in the cardiovascular space.

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Xenios Advances Novel i-cor Synchronized Cardiac-Assist System In Europe

Xenios announced in late November that it had received CE mark for i-cor, an acute mechanical circulatory support device that provides assistance to a failing heart with an external, heartbeat-synchronized system that generates an artificial pulse. The company believes i-cor will open up new therapy options for the hundreds of thousands of patients in acute heart failure (cardiogenic shock) and in those undergoing high-risk interventions in the cath lab – a market opportunity estimated at $5 billion annually in the US and Europe alone.

VADs Set To Enter Big Leagues With St. Jude's Plan To Acquire Thoratec

St. Jude Medical says it will pay $3.4 billion to own ventricular-assist device leader Thoratec, pointing to significant synergies in the heart failure and interventional cardiology markets. The deal would thrust VADs into a diversified cardiology firm for the first time, and it includes a "go-shop" period that leaves an opening for other big device firms to enter competing bids.

HeartWare HVAD Meets Primary Endpoint For Destination Therapy

Results of the 446-patient trial presented at the International Society for Heart and Lung Transplantation Annual Meeting show non-inferiority of the HVAD to FDA-approved ventricular assist devices in destination therapy patients.

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