A Medical Device Daily

Thoratec (Pleasanton, California) and Levitronix (Waltham, Massachusetts) reported they have signed a co-distribution agreement under which Thoratec will distribute the Levitronix CentriMag Blood Pumping System in the U.S.

The agreement is effective through December 2011.

The Levitronix device currently has FDA 510(k) approval in the U.S. for use in patients requiring short-term extracorporeal circulatory support during cardiac surgery. It has CE-mark approval and is commercially available throughout Europe to support patients in severe, potentially reversible ventricular failure for up to 14 days.

The device recently completed three successful pilot trials in the U.S. to demonstrate safety in patients suffering from cardiogenic shock, experienced after cardiac surgery or acute myocardial infraction (AMI), and for patients requiring short-term right ventricular support.

Levitronix is currently in discussions with the FDA to begin an Investigational Device Exemption pivotal trial later this year to demonstrate safety and effectiveness of the CentriMag for any cardiac condition resulting in ventricular failure where there is an opportunity for recovery. These include but are not limited to AMI, post-cardiotomy cardiogenic shock, acute myocarditis, intractable ventricular arrhythmias, failed transplant and postpartum cardiomyopathy.

The company estimates the market opportunity for these indications to be $40 million to $100 million, but does not expect this agreement to represent a meaningful contribution to revenues for the balance of 2006.

“We are delighted to be expanding our relationship with Levitronix, our development partner for the HeartMate III centrifugal, continuous-flow pump,” said Gary Burbach, president/CEO of Thoratec.

In a separate transaction, Thoratec is investing $5 million in Levitronix through a convertible debt instrument that matures in 2013.

AGA Medical (Minneapolis) reported that it has reached an agreement with BVM (Hinckley, UK) to terminate the distribution agreement between the two firms. Terms include an unspecified up-front payment followed by three milestone payments tied to sales of AGA products in the former sales territory during the next three years.

The agreement also provides for support during a transition period while AGA expands the operations of its wholly owned subsidiary, Amplatzer Medical UK. AGA also has agreed to hire key members of the BVM sales team that serviced hospital customers in the UK.

In 1997, BVM was named the first distributor for AGA products worldwide.

The announcement of the termination followed discussions between the two companies over several months regarding a change in the agreement as well as extensive planning for the transition. In addition to providing direct distribution of AGA Medical products in the UK, Amplatzer Medical Ltd. will be used as a platform to expand European operations to better service AGA customers in the region. AGA Medical currently sells directly in Germany, Austria, Switzerland, Sweden, Norway, Finland and Denmark.

Allscripts (Chicago) a provider of clinical software, connectivity and information solutions that physicians use to improve healthcare, reported that Indiana Heart Associates (IHA; Indianapolis) will deploy the TouchWorks Electronic Health Record (EHR) to automate everyday clinical tasks, and enhance the quality and efficiency of patient care.

Allscripts also said that it has entered into a strategic alliance with MedAxiom, an association of more than 220 cardiology groups that aggregates and reports on key clinical and financial data to benchmark and improve performance.

IHA is one of the largest cardiology groups in Indiana and is closely affiliated with the Indiana Heart Hospital. The physician group will use the EHR from Allscripts to connect and automate its 23 cardiologists and six nurse practitioners across nine locations in the Indianapolis area.

Allscripts will market its TouchWorks and HealthMatics EHR to MedAxiom's 4,500 physician members in more than 220 cardiology practices nationwide, gain access to benchmarking data, and participate in the MedAxiom Group Purchasing Organization.

MDD releases new report on orthopedics market

The publishers of Medical Device Daily have just released a new 200-page report focusing on the orthopedics sector, Orthopedics 2006 – Trends, Challenges and Opportunities.The report provides detailed insight into the trends impacting the orthopedics sector.

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