The Optimizer Smart Mini CCM Delivery System is now available from Impulse Dynamics.
FREMONT, CA: Medical device development is transforming an idea for a medical gadget into a marketable product. Development engineers in the medical device sector must adhere to the phases of medical device development, comply with stringent regulatory regulations, and meticulously document their work. Both the FDA and the CE Mark have approved the Optimizer® Smart Mini CCM® treatment delivery system from Impulse Dynamics, a global medical device firm that is dedicated to improving the lives of people with heart failure (HF). The new Optimizer Smart is 25 percent smaller and 33 percent lighter than the current Optimizer Smart, soon available in the United States and Europe.
“I’m excited about the potential of this device to improve quality of life in patients already on optimal medical therapy,” comments Dr. Rhea Pimentel, Director of the Electrophysiology Lab at the University of Kansas Medical Center, who has already implanted the new CCM therapy device in a pre-market evaluation. “We've had a lot of experience with CCM using the Optimizer Smart device, but the next generation Optimizer Smart Mini CCM is simpler to implant and more comfortable for patients.”
"The Optimizer Smart Mini is a major advance for CCM therapy. The combination of a twenty-year battery life and heart failure diagnostic monitoring makes this an incredibly appealing option for patients with heart failure," states Dr. Hirak Shah, a heart failure cardiologist at KUMC and the physician who referred this patient for CCM therapy. "This type of innovation makes me very excited and optimistic about the future of device-based therapies in the field of heart failure."
“Reducing the size of the device and extending its feature set while simultaneously extending its longevity took a great deal of ingenuity and cooperation,” states David Prutchi, Ph.D., Impulse Dynamics Chief Technology Officer and architect of the Optimizer Smart Mini platform. “This device utilizes an entirely new electronic chipset packaged into a compact, physiologically shaped implantable enclosure. The platform also includes a new, feature-rich programmer and charger designed to dramatically simplify the programming and use of the device.”
The new technology provides a battery life extension of 20 years (up from 15 years in the previous generation), advanced HF diagnostic monitoring capabilities (e.g., heart rate, heart rate variability, patient posture, and position), and remote patient monitoring features will be activated shortly.
"The launch of the new platform is another sign of our commitment to helping HF patients live a better life," states Jason Spees, Impulse Dynamics President and Chief Commercial Officer. "Earlier this week, we announced a very significant milestone, bringing hope to the 7,000th CCM patient worldwide. The commercial release of the Optimizer Smart Mini platform offers innovation that makes this therapy easier to use and helps us offer hope to many thousands more HF patients. This is one of many launches to come based on our commitment to a rapid cadence of product innovation to serve a patient population estimated to be at least twice the size of the patient population indicated for cardiac resynchronization therapy."
The Optimizer Smart Mini administers CCM therapy to the heart using the company's patented technology. Impulse Dynamics developed CCM therapy to improve heart contraction significantly, allowing for increased oxygen-rich blood flow throughout the body. CCM therapy is indicated to enhance 6-minute hall walk time, quality of life, and functional status in NYHA Class III heart failure patients who remain symptomatic despite guideline-directed medical therapy, are not candidates for cardiac resynchronization therapy, and have a left ventricular ejection fraction of 25 to 45 percent.