MARLTON, N.J., Oct. 30, 2023 (GLOBE NEWSWIRE) -- Impulse Dynamics, a global medical device company dedicated to improving the lives of people with heart failure (HF), announced today it has received whole-body MRI-conditional approval for the Optimizer® Smart Mini system from the United States Food and Drug Administration (FDA).

MARLTON，N.J.，2023年10月30日（GLOBE NEWSWIRE）-Impulse Dynamics，一家致力于改善心力衰竭（HF）患者生活的全球医疗器械公司，今天宣布它已获得全身MRI有条件批准来自美国食品和药物管理局（FDA）的Optimizer®Smart Mini system。

The Optimizer Smart Mini system delivers the company’s proprietary CCM® therapy. This conditional approval expands the product labeling to allow for full-body magnetic resonance (MRI) diagnostic imaging with 1.5 and 3.0 Tesla (T) scanners. The approval for use with full-body MRI covers new patients adopting CCM therapy as well as existing Optimizer Smart Mini users.

优化器Smart Mini系统提供公司专有的CCM®疗法。此条件批准扩展了产品标签，以允许使用1.5和3.0 Tesla（T）扫描仪进行全身磁共振（MRI）诊断成像。全身MRI使用的批准涵盖了采用CCM治疗的新患者以及现有的优化器智能迷你用户。

“We are pleased to receive approval for this important labeling change reflecting a necessary option for heart failure patients who likely receive multiple surgeries and benefit from the use of MRI imaging in the course of their treatment,” said Jason Spees, CEO of Impulse Dynamics. “This furthers our commitment to supporting the heart failure patients who benefit from important and life-changing CCM therapy with the Optimizer Smart Mini system.” “Full body MRI capability is part of our promise to deliver an ongoing pace of innovation,” said David Prutchi, Ph.D., Chief Technology Officer, Impulse Dynamics.

Impulse Dynamics首席执行官Jason Spees说：“我们很高兴获得这一重要标签更改的批准，这反映了心力衰竭患者的必要选择，这些患者可能会接受多次手术并在治疗过程中受益于MRI成像的使用。”。“这进一步推动了我们致力于通过优化器智能迷你系统支持受益于重要且改变生活的CCM治疗的心力衰竭患者。”Impulse Dynamics首席技术官David Prutchi博士说：“全身MRI能力是我们承诺实现持续创新的一部分。

“This advance will ensure that patients who can benefit from our CCM therapy are able to pursue the option without limiting important future diagnostic options.” The Optimizer Smart Mini delivers CCM therapy to the heart. CCM therapy delivers precisely timed electrical pulses to the heart that are intended to improve the heart’s ability to contract, allowing more oxygen-rich blood to be pushed out through the body.1 CCM therapy is indicated to improve 6-minute hall walk, quality .

“这一进步将确保能够从我们的CCM治疗中受益的患者能够在不限制未来重要诊断选择的情况下追求该选择。”优化器Smart Mini为心脏提供CCM治疗。CCM治疗为心脏提供精确定时的电脉冲，旨在提高心脏的收缩能力，使更多富氧血液通过身体推出.1 CCM治疗可改善6分钟的走廊行走质量。

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Optimizer® Smart Mini System

Optimizer®智能迷你系统

Optimizer® Smart Mini System With Leads Into the Heart

Optimizer®智能迷你系统，将引线带入心脏