A Medical Device Daily

Biotronik (Berlin), a company that makes wireless remote monitoring technology for patients with cardiac devices, has partnered with Belgian biotechnology company Cardio3 BioSciences in its C-Cure stem cell clinical trial. The trial is designed to evaluate the safety and efficacy of Cardio3 BioSciences' second-generation stem cell therapy in patients with heart failure. The first patient was treated in March.

Patients who participate in the trial will receive an implantable cardioverter defibrillator with Home Monitoring. These devices ensure optimal standard of care for patients with severe cardiac conditions, Biotronik said. According to the company, Biotronik Home Monitoring offers the most advanced remote monitoring for cardiac patients employing cellular technology in the third generation. The Home Monitoring system safely reduces the need for conventional in-office visits, while improving follow-up adherence, and enables earlier evaluation of clinically relevant cardiovascular events, the company said.

"This partnership with Cardio3 BioSciences highlights the quality of the Biotronik Home Monitoring system and also provides Biotronik with the opportunity to be directly involved in one of the most innovative areas of medicine. Longer term, what we learn through the trial will allow us to evaluate the potential to combine our innovative device technology with complementary approaches such as stem cell therapy so as to offer outstanding solutions to help to restore and secure the patient's quality of life in a lasting way," said Marlou Janssen, global VP of marketing and sales at Biotronik.

C-Cure is a second generation cell therapy for the treatment of heart failure that involves taking a patient's own stem cells from bone marrow and through a proprietary culturing technology generating differentiated 'cardiopoietic' cells which can regenerate damaged heart muscle. Unlike previous cell therapies for this indication, C-Cure is designed to produce new autologous heart muscle cells, which behave identically to those lost in infarction without carrying the risk of rejection, according to Cardio3.

In the two-phase, multi-center trial, 240 patients suffering from ischemic cardiomyopathy at 35 sites in eleven countries will be treated with C-Cure. The primary endpoint is a change in left-ventricular ejection fraction at six months post treatment.

In other agreements/contracts news, Premier Purchasing Partners (San Diego) reported that new agreements for airway clearance devices have been awarded to Electromed (New Prague, Minnesota); Hill-Rom (Batesville, Indiana); RespirTech (St. Paul, Minnesota); and Thayer Medical (Tucson, Arizona).

Effective May 1, the agreements are available to acute-care and continuum-of-care members of the Premier healthcare alliance.