A Medical Device Daily

Stereotaxis (St. Louis), maker of cardiology instrument control systems for use in a hospital's interventional surgical suite, said it will co-sponsor a post-market, prospective, randomized outcomes-based clinical study to determine the role of magnetic navigation in LV lead placement optimization with Medtronic (Minneapolis).

The study will pair magnetically-guided LV lead implant techniques with select physiological parameters to measure response to pacing in multiple sites within the coronary venous system to determine the best pacing location. This optimized LV lead implant will be compared with conventional lead implant techniques to determine the difference in chronic response to optimized LV lead implant vs. conventional LV lead implants.

“This is an important study to advance the science of CRT and may lead to a change in the acceptable criteria for all CRT implants,” said Carlo Pappone, MD, PhD, of San Raffaele University Hospital (Milan, Italy), the lead investigator in the study.

The study is expected to begin enrollment in the second half of this year.

In other agreements news:

• Baxter International (Deerfield, Illinois) and Jerini (Berlin) reported progress in their collaborative research program to develop a non-intravenous therapy for the treatment of hemophilia. Extensive in vitro and in vivo analyses have identified several synthetic lead molecules with promising pharmacological properties, the companies said.

Jens Schneider-Mergener, Jerini's CEO, said, “We are encouraged by the identification of these molecules and the evaluation of the potential to treat hemophilia using a non-intravenous therapy with molecules that can be synthetically produced.”

Scientists from Baxter and Jerini used tailored screening and analysis methods to design molecules with the ability to promote the coagulation of blood. Following further analysis, several principal molecules that showed promising activity in mouse models of hemophilia were selected for further development.

The collaboration between Baxter and Jerini was initiated in 2001 and expanded in 2004. Jerini received an up-front payment, with the potential for milestone payments for achieving discovery, preclinical and clinical goals as well as royalties in the event of marketing approval.