A Medical Device Daily
Abiomed (Danvers, Massachusetts) said the French regulatory agency for medical devices, the Agence Francaise de Securite Sanitaire des Produits de Sante (AFSSAPS), has granted approval of the AB5000 Circulatory Support System, allowing its sale in one of the largest medical device markets in Europe.
In addition, Abiomed reported plans to open an office in Paris to provide French customers with direct customer service, and sales and clinical expertise as they incorporate ventricular assist device (VAD) recovery programs into standard clinical practice.
All of Abiomed's circulatory support systems, including the company's Impella products, now are available in France, providing French patients in acute heart failure with access to circulatory support.
The AB5000 is a VAD designed to rest and recover a patient's heart following such events as cardiogenic shock resulting from myocardial infarction, myocarditis, postpartum cardiomyopathy, ventricular septal defect, refractory arrhythmias, failed heart transplants, right ventricular assistance with implantable left ventricular assist device (LVAD), and postcardiotomy cardiogenic shock.
The system also allows patients to walk with the support of the console.
“We are excited by the momentum in Europe overall and also with this new access to the French market,” said Michael Minogue, chairman, president and CEO. “We are seeing increased utilization worldwide. Our plan for a new office in France demonstrates our strong commitment to work closely with our customers and clinical leaders in France to assist in the development of recovery programs for their patients.”
The AB5000 was FDA-approved in September 2003 to provide temporary support for one or both sides of the natural heart in circumstances where the heart has failed, giving the patient heart the opportunity to rest and potentially recover and giving surgeons the therapeutic flexibility necessary to determine the best endpoint for treatment.
The AB5000 and the BVS 5000 are the only devices with recovery labeling in the U.S.
In Europe, Abiomed offers the Impella Recover minimally invasive cardiovascular support systems under CE-mark approval. The Impella products are not yet available for sale in the U.S.
Abiomed's global sales and clinical teams now total more than 45 and the company announced recently its intention to hire two to four additional sales and clinical professionals globally per quarter in fiscal 2007.
The AB5000 Ventricle, a major component of the AB5000 Circulatory Support System, is a pneumatically driven blood pump. The sterile, disposable Ventricle provides circulatory support in the presence of left-, right-, or both-sided heart failure. The Ventricle is placed next to the body and can take over the pumping function of the natural heart.
Assisted by vacuum, blood flows from the native heart into the AB5000 Ventricle bladder. The bladder, which holds about 100 cc of blood, fills and empties much like the natural heart. Connection of the Ventricle to the patient is accomplished by connecting the pump to cannulae implanted in the patient's heart. These tubes pass through the patient's skin and connect directly to the AB5000 Console.
The company's AbioCor implantable replacement heart was the subject of an initial clinical trial under an Investigational Device Exemption from the FDA. The AbioCor has not been approved for commercial distribution, and is not available for use or sale outside of the initial clinical trial.
Ministerial appointments in UK
Several ministerial appointments involving the UK Department of Health were repoted earlier this month.
Andy Burnham was named as minister of state for delivery and quality and Ivan Lewis was appointed as parliamentary under secretary of state for care services at the Department of Health.
Burnham had served as under secretary of state at the Home Office for Immigration, Citizenship and Nationality, while Lewis had been economic secretary to the treasury both since May of last year.
Current Minister Caroline Flint has been promoted to minister of state for public health. Lord Norman Warner remains as minister of state for NHS reform, Rosie Winterton as minister of state for health services and Patricia Hewitt as secretary of state for health.
The new policy portfolios for the ministers at the Department of Health include:
• Hewitt – NHS and social care delivery and reform; finance and resources; strategic communications.
• Warner – strategic finance, including allocations and the Comprehensive Spending Review System reform, including SHA/PCT reconfigurations; commissioning; choice; plurality; foundation trusts; independent sector treatment centers; contestability; Payment by Results and system management, including wider review of regulation; Our Health Our Care Our Say White Paper (health lead); community hospitals; unscheduled and emergency care; NHS work force issues; primary care and NHS LIFT; NHS IT/Connecting for Health; departmental management.
• Winterton – international and EU business; emergency preparedness, including pandemic flu; counterfraud; cancer services; cardiac services; diabetes; renal services; mental health, prison healthcare; dentistry; patient and public involvement; equality and diversity issues; fluoridation; chronic diseases; North East, North West and West Midlands SHAs
• Flint – Public Health White Paper implementation, including Health Bill; health inequalities; drugs, including drug treatment; tobacco and smoking; alcohol; physical activity; diet and nutrition; HPA and communicable disease; immunization; sexual health; sustainable development; cross-government health improvement; South East, South Central and South East Coast SHAs.
• Burnham – delivery of targets, including access, 18 weeks and winter; financial recovery; NHS efficiency and productivity, including DH/ALB efficiency, Better Regulation Taskforce, PASA, Logistics and SCEP; PFI and major service reconfigurations; safety and quality, including MRSA, patient safety and the NPSA; professional regulation; clinical negligence, inquiries and investigations; research, pharmacy and healthcare products, including MHRA, NICE pharmaceutical industry, R&D, genetics, biotech, HITF and innovation; ID cards; East Midlands and East of England SHAs.
• Lewis – social care finance, performance and work force issues; social care inspection; maternity services; children's health; older people's services, including intermediate care; physical and learning disabilities, including services for vulnerable adults; and long-term conditions NSF.