A Medical Device Daily

Cambridge Heart (Bedford, Massachusetts) said it has amended its sales and marketing agreement with St. Jude Medical (St. Paul, Minnesota).

St. Jude Medical's sales force now will be able to market Cambridge Heart's HearTwave II Microvolt T-Wave Alternans (MTWA) test to North American primary care and internal medicine physicians. In addition, Cambridge Heart's sales force now will have the ability to support St. Jude Medical's field sales force in all physician markets in North America. Under the original agreement, signed in March (Medical Device Daily, March 23, 2007), the cardiology and electrophysiology markets were to be targeted by St. Jude Medical's field force, and Cambridge Heart's representatives addressed the internal medicine and primary care markets.

"The amendment reflects the growing synergistic partnership between our two field sales forces and highlights the benefits of employing a strategic joint approach. Many patients at high risk for sudden cardiac death are in the care of internal medicine and primary care physicians, and the importance of addressing this population has been recognized increasingly by the CRM industry," said Robert Khederian, interim CEO and chairman of Cambridge Heart. "Expanding the collaborative partnership provides us with an opportunity to penetrate the internal medicine and primary care markets more efficiently. Our two sales forces have worked very well together over the last few months, and by jointly addressing all markets, we can increase awareness for sudden cardiac death and enhance the adoption of MTWA as an effective tool for identifying high-risk patients."

Cambridge Heart said there are no other changes to the agreement, and the company's guidance for 2007 remains $14-$16 million in revenue. Apart from expanding the markets in which Cambridge Heart and St. Jude Medical may work together, the amended agreement retains substantially the same material terms as the original agreement, as outlined in the Form 8-K Cambridge Heart filed with the Securities and Exchange Commission on March 27.

Cambridge Heart's MTWA test measures a specific and extremely subtle pattern of beat-to-beat fluctuations in a person's electrocardiogram, the company said. This pattern of fluctuations is called T-wave Alternans. These tiny variations in the electrocardiogram, measured at one millionth of a volt accuracy, are measured most commonly during a sub-maximal exercise stress test in the physician's office or hospital outpatient setting. Extensive clinical research has shown patients with a positive or non-negative MTWA test are at increased risk for sudden cardiac death (SCD), while those who test negative are at reduced risk, the company noted.

Cambridge Heart develops products for the non-invasive diagnosis of cardiac disease, particularly the identification of those at risk of sudden cardiac arrest.

In other agreement news:

• Teleflex Medical (Research Triangle Park, North Carolina) says it has been awarded five new respiratory care agreements with Novation (Irving, Texas), the healthcare contracting services company of VHA and the University HealthSystem Consortium (UHC).

Teleflex said it received the contracts as a result of Novation's competitive bid process, along with input from the Novation Respiratory Clinical Advisory Council. The agreements are effective July 1, 2007, through June 30, 2010.

The agreements include: Routine respiratory disposables, including masks, cannula, tubing, bubble humidifiers, pre-filled large volume aerosol nebulizers, aerosol drain systems and unit dose solutions; Ventilator disposable products, including those pertaining to active humidification, passive humidification/HME, bacterial/viral filters, heated wire and conventional disposable ventilator circuits; Peak flow meters; Small-volume nebulizers; and Nasal and oral airways, including nasopharyngeal airways and oropharyngeal airways.

Teleflex is a global supplier of disposable medical products, surgical instruments and medical devices.

Novation says it is the leading healthcare contracting services company, delivering unmatched savings and value to nearly 2,500 members of VHA and the UHC, two national healthcare alliances, and nearly 9,000 members of Healthcare Purchasing Partners International (HPPI). Novation develops and manages contracts with more than 500 suppliers, both large and small.

• Baxa (Englewood, Colorado) and Health Robotics (Highland Beach, Florida) reported a strategic alliance to automate the preparation of patient-specific chemotherapy drug admixtures. Health Robotics will optimize its technology for the exclusive use of the Baxa Two-Fer Needles in the automated vial and final containers' access steps for its CytoCare Robot. Baxa Two-Fer Needles provide a unique design that can be used for vented or non-vented vial access, the company said. Their Huber tip prevents vial coring, making it ideal for safe access; whether in an automated device or for manual preparations.

With its CytoCare Robot, Health Robotics says it has the first totally automated system for safe preparation of patient-specific hazardous IV doses.