October 6, 2016 — Xeltis announced this week that patients implanted with its bioabsorbable cardiovascular conduit showed positive functionality results two years after surgery. The data have been presented at the 30th European Association for Cardio-Thoracic Surgery (EACTS) annual scientific meeting, Oct. 1-5 in Barcelona, Spain.

St. Jude Medical Inc. announced a full market release of its EnSite Precision cardiac mapping system and new Sensor Enabled tools in Europe. The new platform is now installed and active in more than 100 sites across Europe and has been used to support more than 5,000 ablation cases since the system’s CE Mark approval in January 2016.

Interventional labs now have an imaging system that provides clinicians flexibility to perform a wide array of procedures with the launch of Toshiba’s Infinix-i Sky +*. The ceiling-mounted system features a double sliding C-arm and 12 x 16-inch flat panel, offering clinicians the potential to increase coverage, speed and patient access.

GE Healthcare recently announced U.S. Food and Drug Administration (FDA) 510(k) clearance of its Discovery MI digital positron emission tomography (PET)/computed tomography (CT) system and shared a series of first clinical images. Built with technology allowing significantly better small lesion detectability, Discovery MI can help clinicians in their efforts to diagnose and stage disease earlier.

October 5, 2016 — Vascular Solutions Inc. initiated a nationwide recall of its Twin-Pass Dual Access catheters used in catheterization procedures. The recall began Sept. 16, 2016. All unexpired lots of the product have been recalled because there is a potential for excess manufacturing material to remain at the tip of the catheter or within the distal portion of the rapid exchange lumen. It is possible that the excess material may separate from the catheter during use and pose a potential risk of embolism, which could result in serious injury or death. 

October 5, 2016 — Medtronic said two previously communicated global voluntary recalls related to the HeartWare International (HeartWare) HVAD System have been classified as Class 1 by the U.S. Food and Drug Administration (FDA). Class 1 recalls describe situations where there is reasonable risk of serious adverse health consequences or death.

GE Healthcare announced that the U.S. Food and Drug Administration (FDA) has approved a label change for the ultrasound contrast agent Optison (Perflutren protein-Type A Microspheres Injectable Suspension, USP). The FDA removed the contraindications for use in patients with cardiac shunts and for administration by intra-arterial injection. Both contraindications have been revised and moved to the WARNINGS AND PRECAUTIONS section (5.3 : Systemic Embolization) of the Full Prescribing Information.

October 4, 2016 — Xeltis recently announced that three pediatric patients have been successfully implanted with the world’s first heart valve enabling cardiovascular restoration. The children have been enrolled in the “Xplore-I” clinical study of the Xeltis bioabsorbable pulmonary heart valve, a multi-centered feasibility trial currently enrolling pediatric patients from 2 to 21 years of age in leading heart centers in Europe.

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