CardioFocus’ Endoscopic Ablator Gains CE Mark to Treat Atrial Fibrillation
CardioFocus received the CE Mark for its HeartLight X3, an endoscopic ablation system used to remove harmful tissue in the body and perform pulmonary vein isolation procedures.
The third-generation product combines a motor control system with laser energy and direct tissue visualization to block abnormal electric pathways responsible for atrial fibrillation.
Atrial fibrillation is a quivering or irregular heartbreak that can cause stroke, heart failure and other adverse events.
FDA Approves Impulse Dynamics’ Heart Failure Device
The FDA approved Impulse Dynamics’ implantable Optimizer Smart System for treating heart failure.
The breakthrough device, which received a 12-0 vote from the FDA’s Medical Devices Advisory Committee in December 2018, is intended for patients who have mildly to moderately reduced left ventricular ejection fractions and aren’t eligible for cardiac resynchronization therapy.
The device delivers an electrical pulse just after the heart contracts to modulate the strength of the heart muscle contraction rather than the rhythm.
Brightwater’s Biliary Stent System Cleared by FDA
The FDA issued 510(k) clearance for Brightwater Medical’s biliary stent system, designed to remove the need for an invasive procedure in treating biliary duct obstructions.
Used by interventional radiologists, the device enables stent release in less than a minute during an in-office visit or at bedside, eliminating the need for sedation or repeated drain insertions.
The stent system helps to treat biliary duct obstructions, which can lead to serious complications including sepsis, liver damage or biliary cirrhosis.
FDA Clears Masimo’s CO-Oximeter
Masimo received 510(k) clearance for its Rad-67 Pulse CO-Oximeter, a device used to measure the oxygen carrying state of hemoglobin in a blood sample.
The portable device performs spot-check monitoring using its DCI-mini sensor, which analyzes total hemoglobin, carboxyhemoglobin, methemoglobin and arterial oxygen saturation.
The single-device solution is suited for use in both clinical and non-clinical settings, such as emergency rooms, physician’s offices and pre- and post-surgery situations.
Zimmer Biomet Earns FDA Clearance for Robotic Spine System
The FDA cleared Zimmer Biomet’s Rosa One Spine System, a device used for robotically assisted minimally invasive complex spine procedures.
The device includes 3D intraoperative planning software and a navigation toolkit to enhance placement accuracy.
The system combines real-time patient tracking capabilities with robotics and navigation to aid in minimally invasive and complex thoracolumbar spine procedures.
FDA OKs Device for Treating Heart Failure
The FDA approved Impulse Dynamics’ Optimizer Smart system, an implantable pulse generator designed to treat moderate to severe heart failure.
The device treats patients who are unable to use other heart failure devices, such as cardiac resynchronization therapy. The device is implanted under the skin in the upper left or right chest area and attached to three leads implanted in the heart.
After implantation, the physician tests and programs the device, enabling it to give electrical impulses to the heart during regular heartbeats and assist in squeezing.