A Medical Device Daily

St. Jude Medical (St. Paul, Minnesota) said that its wireless PressureWire Aeris technology, which aids in the diagnosis and treatment of coronary artery blockages by measuring Fractional Flow Reserve (FFR), will now be available to hospitals using the McKesson (Alpharetta, Georgia) Horizon Cardiology Hemo solution. Through a new agreement with McKesson, physicians will have greater access to the market's only wireless FFR measurement system.

FFR measurement indicates the severity of blood flow blockages in the coronary arteries, allowing physicians to better identify which specific lesion or lesions are responsible for a patient's ischemia, a deficiency of blood supply to the heart caused by blood flow restriction. The technology will help physicians determine the best treatment option for their patients during coronary interventions, such as stent procedures, St. Jude said.

The PressureWire Aeris is a wireless FFR measurement system which requires no additional equipment or cabling in the cardiac catheterization laboratory. The elimination of additional equipment and cabling has the potential to simplify set-up and increase procedural efficiencies, the company said.

The wireless technology works by integrating physiological lesion assessment directly into the hemodynamic recording system already available in the cath lab to immediately display, measure and save FFR data. This integration is an optional module for hospitals using McKesson's Horizon Cardiology Hemo system version 12.1. The McKesson Horizon Cardiology Hemo system was designed to improve the overall workflow of the entire catheterization suite. A single interface in the Horizon Cardiology Hemo system combines both the FFR measurement controls and clinical documentation including lesion, stage and medication. This integration between the PressureWire Aeris wireless technology and the Hemo system v 12.1 provides availability of this important clinical data in the physician report and registry submission modules.

Two-year follow-up data from the Fractional flow reserve (FFR) vs. Angiography in Multivessel Evaluation (FAME) trial compared FFR-guided treatment using a St. Jude Medical PressureWire to treatment using standard angiography alone, and found both superior clinical outcomes and reduced healthcare costs in patients whose treatment was based on FFR. The combined risk of death or myocardial infarction (heart attack) was 34% lower for patients whose treatment was guided by PressureWire technology prior to coronary stenting.

FFR-guided treatment using the St. Jude Medical PressureWire System was also found by the FAME trial to be cost-saving, with a difference of about $2,000, or 14%, in healthcare costs to the hospital between the two patient groups after one year.

In other agreements/contracts news:

• Cantimer (Menlo Park, California) and Advanced Instruments (Norwood, Massachusetts) have signed a license and product development agreement. Advanced Instruments received an exclusive license to Cantimer's unique sensor technology for select applications in the biotech market. The companies also entered into a product development agreement for Cantimer to develop a specific sensor to integrate into Advanced Instruments' products for in-situ monitoring of osmolality in bioreactors and fermenters. The companies anticipate that a long-term sensor supply agreement will follow the joint development effort and that developed products will be sold to end-users through Advanced Instruments' existing commercial network.

"Monitoring osmolality is a critical control parameter in the biotech market. Traditionally this has been accomplished using discreet samples on a laboratory instrument. Cantimer's unique sensor technology makes it possible to measure osmolality in the bioreactor and in real time, reducing the possibility of product contamination and enabling tighter product quality control" said John Coughlin, CEO of Advanced Instruments.

Cantimer makes point-of-care technology platforms; Advanced Instruments makes freezing-point cryoscopes and osmometers.

• Amedica (Salt Lake City), a spinal and orthopedic implant and instrument company focused on silicon nitride (SiN) ceramic technologies, reported an agreement with Orthopaedic Synergy (Raynham, Massachusetts), a holding company for OMNIlife Science and Enztec, both designers, manufacturers and distributors of reconstructive surgery implants and instrumentation.

Amedica claims its SiN material is fracture resistant; its bearing/articulating surfaces do not produce wear debris that is linked to osteolysis-related, re-operations. Additionally, the implants are BioActive with a hydrophilic surface and a conductive cancellous structure to enhance bone in-growth and attachment.

The agreement will allow the development, regulatory approval and distribution of SiN articulating hip and knee implants in the U.S. and abroad.

"Amedica's SiN technology is ideally suited for the innovative modular hip and knee replacement products developed and marketed by our company, and we view this Joint Venture Development Agreement as a significant step forward in solving the issue of wear in reconstructive orthopaedic products," said Nik Nikolaev, CEO of Orthopaedic Synergy.