Sunshine Heart, a global medical device company focused on developing technologies to address heart failure, recently announced a significant update to the company’s next-generation, completely implantable version of flagship C-Pulse® technology, noting that it will start a first-in-human project utilizing the new transcutaneous energy transmission (TET) system and a new smaller implantable pump in the third quarter of 2016. The company believes that these new initiatives will lead to improved heart failure prevention in patients outfitted with the technology.
The study will begin enrolling patients at hospitals outside the United States and will be focused on patients who suffer from advanced Class III/IV heart failure, which is very similar to the patient population of Sunshine Heart’s current ongoing COUNTER HF™ Study. The safety, feasibility of implant, and short term durability will be the main endpoints evaluated in the study. Both efficacy and performance data will be gathered to assess patient quality of life, absence of heart failure symptoms and other standard heart failure measures such as the ability to bridge to other therapies.
William Cohn from the Texas Heart Institute, a researcher highly committed to the advancement of Sunshine Heart’s new program, will lead the study, commenting: “the development of a completely implantable circulatory assist device that obviates the need for a driveline will be an important milestone in the evolution of heart failure therapies. The system will also be non-blood contacting and non-obligatory and may prove to be a real game changer for patients with intermediate stage heart failure.”
The company’s fully implantable system could eliminate the need to manage a driveline, which can lead to the risk of site infections. The system could substantially improve the quality of life of patients at risk for heart failure and, as the company believes, increase market access to responding to the medical needs of all Class III HF patients, just like CRM and neuromodulation devices. Furthermore, the unique ability for Sunshine Heart to deliver chronic counter pulsation therapy and increase coronary blood flow through the C-Pulse® technology may offer a new market opportunity to treat angina and ischemic heart disease, where mortality and morbidity remain high in heart failure populations with reduced and preserved ejection fraction.
The benefits of counter pulsation and C-pulse on the pulmonary circulation and the high prevalence of pulmonary hypertension in the latter population might also provide for a therapeutic opportunity with a fully implantable system as well.