Integer Expands Relationship with Impulse Dynamics

Integer Holdings Corporation, a medical device outsource (MDO) manufacturer, announced that its Greatbatch Medical subsidiary has signed a development agreement with Impulse Dynamics to co-develop its next-generation lead system for cardiac contractility modulation (CCM) therapy. In addition, the companies also have agreed to negotiate a supply agreement for the associated products under the development agreement.
 
CCM is a method for treating moderate-to-severe heart failure by delivering non-excitatory electrical pulses to the heart. By leveraging Integer’s existing technology platform with Impulse Dynamics’  specifications, Impulse Dynamics will be able to deliver a fully customized lead solution to the CCM market 12 to 16 months earlier than developing one on their own. Clinical trials have shown that CCM treatment significantly improves exercise tolerance and quality of life in a subset of symptomatic heart failure patients. According to the Journal of the American College of Cardiology, heart failure is a global public health problem affecting an estimated 26 million worldwide. In the United States alone, the prevalence is 5.7 million with 670,000 new cases each year.
 
“We look forward to growing our cooperation with the Integer organization. We believe that Integer’s track record in implantable device development will accelerate the successful delivery of Impulse Dynamics’ next-generation cardiac stimulation lead specifically designed for the most effective delivery of CCM therapy to heart failure patients,” said David Prutchi, executive vice-president, product development, at Impulse Dynamics.
 
“This is an exciting collaboration for Integer and an expansion of our long-standing relationship with Impulse Dynamics,” said Tony Gonzalez, president of Integer’s Cardiac Rhythm Management & Neuromodulation product line. “This agreement further enhances Integer’s position as a developer and manufacturer of leads for our customers in the active implantable market and also speaks to our full systems capabilities to deliver solutions efficiently that meet our customer’s needs quickly.”
 
Integer Holdings Corporation is one of the largest medical device outsource manufacturers in the world, serving the cardiac, neuromodulation, orthopedics, vascular, advanced surgical and portable medical markets. The company provides high-quality medical technologies that enhance the lives of patients worldwide. In addition, it develops batteries for high-end niche applications in energy, military, and environmental markets. The company’s brands include Greatbatch Medical, Lake Region Medical and Electrochem.
 
Impulse Dynamics N.V., a member of the Hobart Group companies, is focused on the development of electrical therapies for the treatment of chronic heart failure. As a leader in cardiac medical innovation, Impulse Dynamics has operations in the United States, Europe, Asia, and Australia. CCM and Optimizer are trademarks of Impulse Dynamics N.V.
 
The Hobart Group develops and commercializes medical technologies which target top healthcare markets with significant unmet needs. Its growing portfolio of companies covers the areas of cardiology, diabetes, oncology, neurology and rehabilitation. Together, Hobart Group companies have nearly 200 scientists, engineers, regulatory and business experts across four continents, benefitting from clinical expertise and extensive regulatory and international market knowledge across Europe, the United States and Asia.