CARDIOLOGY
CARDIOLOGY
Easy to Use Navik 3D Cardiac Mapping System Cleared in U.S.
APN Health, a firm based in Wisconsin, got hold of an FDA clearance to introduce its Navik 3D cardiac mapping system in the U.S. The system provides live tracking of catheters in 3D gathered from fluoroscopic 2D images, and combines that with...
CARDIOLOGY
InterAtrial Shunt Device Tested for Diastolic Heart Failure
At the Ohio State University Wexner Medical Center clinical researchers have begun studying a new treatment for diastolic heart failure, an increasingly recognized cardiac problem. The new InterAtrial Shunt Device from Corvia Medical...
CARDIOLOGY
Boston Sci's ACUITY X4 Quadripolar Left Ventricular Leads Approved in U.S.
Boston Scientific landed FDA's approval for its ACUITY X4 Quadripolar Left Ventricular leads for use with the firm's cardiac resynchronization therapy devices (CRTs). The four electrodes on the leads allow cardiologists to choose from a greater...
CARDIOLOGY
Mitralign Minimally Invasive System for Mitral Regurgitation Cleared in Europe (VIDEO)
Mitralign, a Tewksbury, MA firm, won European regulatory approval to introduce the Mitralign Percutaneous Annuloplasty System (MPAS) for repair of functional mitral regurgitation. The Mitralign system offers a minimally invasive ability for...
CARDIOLOGY
Medtronic's CRT-Ds Now Approved for 3 Tesla Scanning in Europe
Medtronic won European CE Mark approval for a number of its cardiac resynchronization therapy defibrillators (CRT-Ds) to be safe for use under MRI imaging of up to 3 Tesla. The approved devices include the Claria MRI Quad CRT-D SureScan, Amplia MRI...
CARDIOLOGY
St. Jude Medical's MultiPoint Pacing Technology Coming to America
St. Jude Medical landed FDA approval of its MultiPoint pacing technology that is available through the Quadra Assura MP cardiac resynchronization therapy defibrillator, the Quadra Allure MP CRT-pacemaker, and two of the company's quadripolar...
CARDIOLOGY
Spectranetics Bridge Occlusion Balloon Plugs Large Vessel Tears Caused by Lead Extractions
Spectranetics, a Colorado Springs, CO firm, won FDA 510(k) clearance for its Bridge Occlusion Balloon, a device used to block large vessels, typically the superior vena cava (SVC), if a tear happens while removing cardiac leads. Though tears are...
CARDIOLOGY
St. Jude's OPTIS Mobile System Combines OCT, Angiography, FFR In a Mobile Package
St. Jude Medical is releasing in Europe and Japan its OPTIS Mobile System that combines optical coherence tomography (OCT) and angiography co-registration with fractional flow reserve (FFR) measurement. Offering similar features as the...
CARDIOLOGY
Medtronic's MRI-Conditional CRT-Ds Approved by FDA
Medtronic received FDA approval for its Amplia MRI Quad CRT-D SureScan and Compia MRI Quad CRT-D SureScan cardiac resynchronization therapy defibrillators, making them the only MRI-conditional CRT-Ds so far to be available in the U.S. The...
CARDIOLOGY
BIOTRONIK MRI-Compatible Ilivia ICDs and CRT-Ds with MRI AutoDetect Approved in Europe
BIOTRONIK won the European CE Mark to introduce its Ilivia ICD and CRT-D implants that feature the firm's ProMRI and MRI AutoDetect technologies. MRI-compatible cardiac implants are not new anymore, but existing devices have to be reprogrammed...
CARDIOLOGY
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