Just a few weeks after Abbott presented the successful results of a trial of its Aveir DR dual-chamber leadless pacemaker system—data that it said had been promptly submitted for regulatory review—the company has secured FDA approval for the technology.

在雅培提出其Aveir DR双腔无铅起搏器系统数据的试验成功后的几周内，该公司表示已立即提交监管审查，该公司已获得FDA批准该技术。

Like other leadless pacemakers before it, the Aveir DR implant offers an alternative to a standard pacemaker to help maintain a steady heart rhythm in people who experience irregular or slower-than-usual heartbeats. Not only are leadless pacemakers smaller than their predecessors but, as the name suggests, they also cut out the thin wires that connect traditional pacemakers from where they’re placed near the collarbone to the heart—leadless pacemakers are instead implanted directly into the heart..

像之前的其他无铅起搏器一样，Aveir DR植入物提供了标准起搏器的替代品，有助于在经历不规则或比平常心跳慢的人中保持稳定的心律。无铅起搏器不仅比以前的要小，而且顾名思义，它们还切断了将传统起搏器从锁骨附近的传统起搏器连接到心脏的细线。无铅起搏器直接植入心脏。。

Unlike the other leadless pacemakers that have so far been authorized by the FDA, however, Abbott’s newly approved system allows for two of the miniaturized implants to be used simultaneously. That allows it to better serve people who require pacing in two chambers of the heart, a group that makes up more than 80% of all people requiring pacemakers, according to Abbott..

然而，与迄今为止已获得FDA批准的其他无铅起搏器不同，雅培新批准的系统允许同时使用两种微型植入物。根据雅培的说法，这使得它能够更好地为需要在心脏的两个腔室中起搏的人提供服务，这个群体占所有需要起搏器的人的80%以上。。

With the FDA’s approval, which Abbott announced Wednesday, doctors will now be able to implant a pair of single-chamber devices and connect them using Abbott’s i2i communication technology. The Aveir DR system combines Abbott’s previously approved Aveir VR device, which is placed in the right ventricle—like other leadless pacemakers on the market—and the newly authorized, slightly smaller Aveir AR device, designed to help pace the right atrium..

随着雅培星期三宣布的FDA批准，医生现在可以植入一对单室设备，并使用雅培的i2i通信技术连接它们。Aveir DR系统结合了Abbott之前批准的Aveir VR设备和市场上其他无铅起搏器一样放置在右心室中的新授权的稍小的Aveir AR设备，旨在帮助调节右心房。。

Each of the pacemakers is smaller than a AAA battery, according to Abbott, and they’re each inserted into their respective chambers of the heart in minimally invasive procedures. The devices screw into the heart’s interior surface using a mechanism that, per their maker, allows for easy retrieval if replacement or removal is needed in the future..

根据雅培的说法，每个起搏器都小于AAA电池，并且它们都以微创手术插入各自的心脏腔室。这些设备使用一种机构拧入心脏的内表面，如果将来需要更换或拆卸，每个制造商都可以轻松取回。。

Once the pacemakers are in place, the i2i technology uses high-frequency pulses to send beat-to-beat information through the blood between the pair of devices, allowing them to conduct either totally synchronized pacing or another coordinated rhythm.

一旦起搏器就位，i2i技术使用高频脉冲通过一对设备之间的血液发送逐搏信息，使他们能够进行完全同步的起搏或另一种协调的节奏。

“Leadless pacemakers have been limited to a single-chamber device because seamless, wireless synchronization of two pacemakers has been an insurmountable engineering challenge—until now,” Randel Woodgrift, senior vice president of Abbott’s cardiac rhythm management business, said in the announcement..

雅培心律管理业务高级副总裁兰德尔·伍德格里夫特（Randel Woodgrift）在公告中说：“无铅起搏器仅限于单腔设备，因为迄今为止两个起搏器的无缝无线同步一直是不可逾越的工程挑战。。

In study results presented at the Heart Rhythm Society’s annual meeting in May, Abbott reported that the Aveir DR system had met all of its safety and efficacy endpoints across the first 300 participants in a clinical trial.

在5月份心律协会年会上发表的研究结果中，雅培报告说，Aveir DR系统在临床试验的前300名参与者中满足了其所有安全性和有效性终点。

Not only were more than 98% of the implants successful, but almost as many participants, 97%, achieved atrioventricular synchrony—in which the upper and lower chambers of the heart both beat normally—within the first three months of implantation. Additionally, per Abbott, they were able to sustain that synchrony as they changed postures and walking speeds, with a success rate of around 95%..

不仅超过98%的植入物成功，而且几乎同样多的参与者（97%）实现了房室同步，其中心脏的上下腔室在植入的前三个月内均正常搏动。此外，根据雅培，他们能够保持这种同步性，因为他们改变了姿势和步行速度，成功率约为95%。。