Tele: 561.316.3330
Breaking Medical Device News

Wednesday, October 20, 2021

MEDICAL DEVICE NEWS MAGAZINE

A DIGITAL PUBLICATION FOR THE PRACTICING MEDICAL SPECIALIST, INDUSTRY EXECUTIVE AND INVESTOR
HomeImpulse DynamicsImpulse Dynamics Next Generation Optimizer® Smart System Receives FDA Approval

Impulse Dynamics Next Generation Optimizer® Smart System Receives FDA Approval

Commercial-Ready Device to Deliver Improved Outcomes to Heart Failure Patients

The Optimizer Smart System offers a new therapy for heart failure patients with reduced ejection fraction who are still suffering from the debilitating effects of the disease despite guideline-directed medical therapy. New algorithms in the two-lead version of Optimizer Smart deliver therapy just as the previous device did, but no longer require inputs from an atrial lead. Recent evidence from the FIX-HF-5C2 clinical study indicates that patients who received the two-lead system experienced better outcomes, including improved peak VO2 (a common measure of exercise tolerance), and fewer device-related complications.1

“I’ve had the opportunity to provide CCM therapy using both the two-lead and three-lead Optimizer Smart systems. In my opinion, this approval represents an important advancement that will make this breakthrough therapy even more accessible to patients,” said cardiac electrophysiologist Dr. Thomas Mattioni, Scottsdale, Ariz. “Patients with Class III heart failure who remain unresponsive to conventional therapy have few options, and CCM is an important addition to our armamentarium in this respect. I have several patients who have had a remarkable response to CCM, and think it is an option providers should be able to consider for patients who are appropriately indicated.”

CCM is a unique electrical therapy delivered during the heart’s absolute refractory period, which is just after the heart muscle contracts. In contrast to a pacemaker or defibrillator, CCM works by modulating the strength of the heart muscle contraction rather than the rhythm. The Optimizer Smart System is the first and only CCM device approved by the FDA to improve 6-minute hall walk distance, quality of life and functional status of NYHA Class III heart failure patients who remain symptomatic despite guideline directed medical therapy, who are in normal sinus rhythm, are not indicated for CRT, and have a left ventricular ejection fraction (LVEF) ranging from 25 to 45 percent. Only 30 percent of moderate to severe chronic heart failure patients are candidates for CRT, which historically has left 70 percent of patients with few options to help them manage their disease.

“The benefits of Cardiac Contractility Modulation have now been proven with evidence-based medicine and in my clinical practice,” said Dr. Ben D’Souza, Assistant Clinical Professor at Penn Medicine, Philadelphia. “Patients already receive significant benefit from this therapy in its present form and removing the need for an atrial lead is an important advancement for both patients and providers.”

Designed to address a significant unmet medical need in heart failure, the Optimizer Smart System received Breakthrough Device designation from the FDA in 2015. It was the first Breakthrough Device to go before the Circulatory System Devices Panel of the FDA’s Medical Devices Advisory Committee, on Dec. 4, 2018, receiving a unanimous recommendation for approval based on their assessment of benefit versus risk. Optimizer then went on to receive FDA approval on March 21, 2019.

“With the recent commercial launch of this technology in the U.S. market, we have already seen patients make decisions for CCM therapy that clearly indicate and reinforce the significant gap in therapeutic options for this large population of patients in need. This improvement in our platform allows us to bring innovations that deliver hope to more patients than ever before,” said Chris Baer, Vice President of Commercial Operations, Impulse Dynamics.


1 Data on file

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

Stay Connected

spot_img

Don't Miss

Contraline Closes $10.7 Million Series A Financing to Become a Clinical Stage Company

This infusion of capital will support the initiation of a first-in-human trial of ADAM™, the world’s first hydrogel implant designed to provide long-lasting, non-permanent contraception for men.

Adam S. Epstein New CEO of AliMed, Inc.

In his prior role as Chief Commercial Officer, Epstein directed all customer-facing, demand generation and product development activities. Under his new leadership, AliMed will continue to build a robust portfolio of contracted positions with major, national GPO’s, IDN’s, and Distribution partners to drive sales growth.

Tony Collins Appointed CFO of Xenter

“Xenter is building a platform for medical innovations that is transformational. The only way we can achieve our objectives is if we have great leaders like Tony Collins leading our company,” stated Richard J. Linder, Founder, Chairman & CEO of Xenter, Inc. “Tony brings incredible depth and experience to his new role as Chief Financial Officer.

Scott Sexton Appointed President at FIGUR8

"Scott brings to FIGUR8 30 years of workers' compensation, casualty, disability, and commercial health experience, most recently serving as a market leader for CorVel's national carrier practice sales team," said Nan-Wei Gong, CEO, and co-founder of FIGUR8.

Insulet Announces Board of Director Changes with Appointment of Luciana Borio, M.D. and Retirement of Sally W. Crawford

Luciana Borio MD is a respected physician with vast experience in advancing major regulatory and policy agendas for the United States.

Ganymed Robotics Awarded a €2.5M Grant from the EC through the EIC Accelerator Program

Ganymed Robotics is developing a radically new approach to surgical robotics by combining computer vision, a branch of artificial intelligence, and mechatronics.

By using this website you agree to accept Medical Device News Magazine Privacy Policy