FDA批准雅培的sensor-enabled flexible消融导管

医生可以使用带有传感器的FlexAbility导管与Abbott的EnSite Precision心脏图谱系统。


在Abbott收购St. Jude Medical的过程中,FlexAbility消融导管,基于传感器的是基于后者的FlexAbility平台,第一个灌注消融导管,具有弹性尖端到达美国市场。

该公司在一份声明中说,传感器版本收集电流电阻和磁数据以进行详细和准确的映射。它可以与EnSite Precision心脏映射系统和公司的MediGuide技术一起使用。这两个系统也在圣犹达交易中收购。

“我们正在继续创新EnSite精密心脏映射系统,以创建一个最佳支持医生寻找解决最棘手案例的消融组合,”雅培的电生理业务的医疗主任Srijoy Mahapatra,在声明中说。 “… [传感器使能的导管]提供了接合磁性平台以提高精度的能力,特别是当医生遇到复杂情况时。


心室心律失常服务主任Jeffrey Winterfield和心脏电生理学副教授Jeffrey Winterfield表示:“我看到越来越多的复杂心律失常患者出现了对高级工具的强烈需求,可以满足这些患者的需要。南卡罗来纳医科大学在声明中。 “传感器使能的导管,以及EnSite精密心脏映射系统,允许我快速识别和治疗心律失常,给我的灵活性和准确性,我需要达到最具挑战性的位置在心脏,以支持有效的结果,改善我的生活耐心。”


FDA greenlights Abbott’s sensor-enabled flexible ablation catheter

Physicians can use the sensor-enabled FlexAbility catheter with Abbott’s EnSite Precision cardiac mapping system.

Abbott scored FDA approval for its sensor-enabled catheter for the treatment of atrial flutter, a type of cardiac arrhythmia. It is the company’s first ablation catheter that collects data to facilitate mapping in addition to treating the arrhythmia.

Picked up in Abbott’s acquisition of St. Jude Medical, the FlexAbility Ablation Catheter, Sensor-Enabled is based on the latter’s FlexAbility platform, the first irrigated ablation catheter with a flexible tip to hit the U.S. market.

The sensor-enabled version collects electrical current resistance and magnetic data to enable detailed and accurate mapping, the company said in a statement. It may be used with the EnSite Precision cardiac mapping system and the company’s MediGuide Technology. Both systems were also acquired in the St. Jude deal.

“We are continuing to innovate around the EnSite Precision cardiac mapping system to create an ablation portfolio that best supports physicians looking to tackle even the toughest cases,” Srijoy Mahapatra, M.D., medical director of Abbott’s electrophysiology business, said in the statement. ” … [the sensor-enabled catheter] offers the ability to engage the magnetic platform for enhanced precision, especially when physicians encounter a complex case.”

When the catheter is paired with the EnSite system, the physician may create 3D cardiac models with an overlay showing the heart’s electrical activity, the company said. This help the physician determine the type of arrhythmia and identify areas that he or she should ablate.

“I am seeing an increasing number of patients with complex cardiac arrhythmias, which has created a strong need for advanced tools that can meet the needs of those patients” said Jeffrey Winterfield, M.D., director of ventricular arrhythmia service and associate professor of cardiac electrophysiology at the Medical University of South Carolina, in the statement. “Sensor Enabled catheters, along with EnSite Precision cardiac mapping system, allow me to quickly identify and treat the arrhythmia, giving me the flexibility and accuracy I need to reach the most challenging locations in the heart to support effective outcomes and improve the lives of my patients.”