St. Jude Medical said recently the FDA cleared its new delivery tools designed to give physicians greater control and precision when placing cardiac pacing leads. The CPS Duo stylet and guide wire system, the PCS Courier guide wire and the Mond stylet are all tools designed to place leads in precise positions that can be difficult to access.

The Sorin Group said the FDA approved to market the CRT model of its OVATIO family, reportedly the smallest CRT defibrillator (CRT-D) available. The OVATIO CRT 6750 is shaped to offer ease of implantation and long-term patient comfort, and is designed to allow more flexibility in the management of cardiac resynchronization and antitachyarrhythmia therapy due to its Brady-Tachy Overlap (BTO).

Thoratec Corp. received FDA approval of its PMA (premarket approval) application, allowing the use of its HeartMate II LVAS (left ventricular assist system) as a bridge-to-transplantation (BTT) in patients suffering from advanced-stage heart failure.

The FDA cleared Boston Scientific’s ALTRUA family of pacemakers, which enables the company to introduce its first Boston Scientific-branded pacemaker to treat bradycardia.

The Abiomed Inc. Impella 2.5 cardiac assist device was FDA cleared in 2008 for use for partial circulatory support for periods up to six hours. The intra-aortic balloon pump (IABP) also has 510(k) clearance and approximately 110,000 are used each year in the U.S.

The StarClose SE Vascular Closure System is a next-generation vessel closure device engineered to enable fast and secure closure of the femoral artery access site following a catheterization procedure.

Siemens' ACUSON SC2000 volume imaging ultrasound system acquires nonstitched, real-time full-volume 3D images of the heart in one single heart cycle. Called “Echo in a Heartbeat,” this new technology generates nonstitched full-volume imaging reportedly of the entire heart with 90 degree pyramids and in just one second.

The FDA cleared GE Healthcare’s new LightSpeed CT750 HD, said to be the world’s first high-definition CT scanner that produces images 100 times faster with up to 33 percent greater detail through the body and up to 47 percent greater detail in the heart.
CT750 HD reduces dose by up to 50 percent across the entire body and by as much as 83 percent for cardiac scans.

Summit Doppler Systems upgraded the Vista AVS, a full-featured arterial physiologic exam system, which allows clinicians to perform the ankle brachial index (ABI) exam for the diagnosis of peripheral arterial disease (PAD) in the seated position.

The ACUSON SC2000 volume imaging ultrasound system acquires nonstitched, real-time full-volume 3D images of the heart in one single heart cycle.
This new technology generates nonstitched full-volume imaging of the entire heart with 90 degree pyramids in one second.

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