67 WALL STREET, New York - August 15, 2012 - The Wall Street Transcript has just published its Medical Devices Report offering a timely review of the sector to serious investors and industry executives. The full issue is available by calling (212) 952-7433 or via The Wall Street Transcript Online.
Topics covered: Orthopedics and Cardiovascular Medical Devices - Medtech Tax Affects Earnings
Companies include: Abiomed Inc. (ABMD) and many others.
In the following excerpt from his interview in the Medical Devices Report, the CEO, President and Chairman of Abiomed discusses the outlook for his company:
TWST: Would you start with a brief overview of the history and evolution of Abiomed?
Mr. Minogue: Sure. Abiomed has been around since 1981. It was initially started to develop an artificial heart, and it succeeded in 2001 with the AbioCor, the world's only totally implantable artificial heart. I was fortunate enough to take over as the CEO in 2004, at which time I led the effort to refocus the company on the larger market opportunity of minimally invasive heart pumps.
Abiomed's flagship product is the Impella, which is the world's smallest heart pump. It's smaller in circumference than a pencil and about 10 centimeters to 12 centimeters in length at the end of a small catheter. The Impella is inserted, completely percutaneously and within minutes, through a small hole in the leg and up through the aorta into the left ventricle, which is the main pumping chamber of the heart. It does not require a sternotomy, or having your chest cracked open.
The Impella pump delivers 2.5 to five liters of blood flow per minute right into the root of the aorta. Using a pump allows the heart to work less and assures that oxygenated blood is getting to the coronary arteries to fuel the heart itself and the aorta, which then feeds all the other important arteries and organs in the body.
The Impella 2.5 is cleared by the FDA for partial circulatory support for up to six hours and in Europe and Canada for multiple indications, like high-risk PCI and AMI, for up to five days of support. The device can be used prophylactically to ensure backup blood flow during other cardiac procedures or it may be used in emergency patients who require circulatory support.
The Impella 2.5 pump received 510(K) FDA clearance in 2008, and as of the end of the most recent quarter in March 2012, was being used in 631 catheterization, or cath, labs in the United States. The Impella device has achieved greater than 30% year-over-year growth for the past 10 quarters, and is becoming the standard of care for hemodynamic support.
TWST: If someone is suffering from a failing heart and they are treated with Abiomed technology, what would be the result?
Mr. Minogue: The goal is to send the patient home with his own heart. So if it's a prophylactic case, the patient can get treatment that hopefully can improve the heart's performance and the interventional cardiologist can use Impella as partial circulatory support during the procedure to ensure the best possible outcomes.
And if it's an acute condition, where the heart's not pumping enough blood, the Impella device may be used to augment the pumping action and deliver oxygenated blood to the heart itself, as well as the brain and other end organs. This helps stabilize the patient. And then over time, again the goal is for the patient to eventually improve enough so that he can be discharged and go home with his own heart, potentially avoiding the need for other more invasive and expensive procedures.
TWST: Last month, the company received approval from Health Canada, and the EU before that, for the Impella cVAD device. When will this product begin clinical study in the United States?
For more from this interview and many others, visit the Wall Street Transcript - a unique service for investors and industry researchers - providing fresh commentary and insight through verbatim interviews with CEOs and research analysts. This special issue is available by calling (212) 952-7433 or via The Wall Street Transcript Online.