Percutaneous Heart Valve Technology: The Mitral Challenge

Article preview reprinted Medtech Insight - February 2009

While there is no question that heart valve repair and replacement is moving toward minimally invasive techniques and devices, there is a big difference between a minimally invasive surgical approach and a truly percutaneous, incisionless procedure.

Article preview reprinted Medtech Insight - February 2009

Percutaneous Heart Valve Technology: The Mitral Challenge

Most surgeries to replace or repair malfunctioning heart valves are still performed in the traditional, highly invasive way—by opening the chest and stopping the heart. As a result, many patients who might benefit from these procedures do not get them because they are deemed too unstable or high risk to undergo the operation. Recently, however, this field has witnessed an explosion of technology designed to achieve valve repair or replacement without the need for open heart surgery, using minimally invasive surgical or even percutaneous technologies. This ongoing wave of innovation has captured the imagination of investors and entrepreneurs alike, all taken by the opportunity to move heart valve disease into the hands of interventional cardiologists, much like stenting did for coronary artery disease, creating a huge new device market in the process.

But while there is no question that heart valve repair and replacement is moving toward minimally invasive techniques and devices, there is a big difference between a minimally invasive surgical approach and a truly percutaneous procedure that accesses the heart entirely through the vasculature and requires no chest incision. The challenges of reaching the latter goal are substantial, but apparently not insurmountable, and in recent years catheter-based valve technologies have moved closer to mainstream use than ever before. In fact, recent progress in this field provides hope that in the not too distant future percutaneous valve replacement and repair will become an accepted part of the treatment armamentarium, greatly expanding the number of patients who can be offered these potentially life-saving procedures.

There is still a good distance to go before this goal becomes clinical reality, but the signs are encouraging and the field appears to be moving in the right direction. Two first-generation transcatheter aortic valves are now on the market in Europe and the first of these devices may reach the US in 2010 or 2011. Some estimate the market opportunity for transcatheter aortic valve replacement devices could exceed $1 billion in the US and Europe by 2014. (See "Heart Valve Market: PAVR Poised for Growth," Medtech Insight, January 2009. However, there is another big opportunity out there that has attracted the attention of a large number of both established and emerging competitors: mitral valve regurgitation, a vastly underserved market with the potential to far surpass aortic valve replacement in terms of both procedures and revenues.

MR: An Underserved and Expanding Opportunity

Located on the left side of the heart, the mitral valve controls filling of the left ventricle (LV), the heart's main blood pumping chamber, opening during diastole to allow blood from the left atrium to flow into the LV, and then closing again to prevent blood from leaking backwards when the ventricle contracts. The effect is a regular opening and closing of the valve that occurs in sync with the heartbeat.

Unfortunately, there are several things that can go wrong and prevent the flaps, or leaflets, that make up the mitral valve's opening from sealing tightly when the valve is closed. When the leaflets don't seal tightly, blood leaks from the valve, and depending on how severe the leakage is, this condition, called mitral insufficiency or mitral regurgitation (MR), can impact the heart's pumping efficiency, causing it to work harder to clear the regurgitated blood.

Purchase this article online as a PDF and receive it immediately via email. Questions? Call (800) 332-2181. 100% Satisfaction Guaranteed.

Companies mentioned in this article:

AGA Medical Holdings Inc.

Abbott Laboratories Inc.

Ample Medical Inc.

Aortech International PLC

ArthroSurface Inc.

Boston Scientific Corp.

Cardiac Dimensions Inc.

Cardiosolutions Inc.

Cleveland Clinic

Columbia University

New York-Presbyterian Hospital

CoreValve Inc.

Edwards Lifesciences Corp.

Endovalve Inc.

Evalve Inc.

Johnson & Johnson

Cordis Corp.

Medtronic Inc.

MiCardia Corp.

MitralSolutions Inc.

Mitralign Inc.

Myocor Inc.

NeoChord Inc.

Spirus Medical Inc.

St. Jude Medical Inc.

University of Pennsylvania

ValveXchange Inc.

Viacor Inc.

Medtech Insight delivers the quality content you need on medical technologies impacting the spectrum of surgical, orthopedic, cardiovascular, and other markets. Written and edited by seasoned industry participants and experts, the Medtech Insight newsletter provides insights into the technology and market developments (devices, instrumentation, biomaterials, gene therapy, tissue engineering, etc.) impacting a wide range of surgical and non-surgical clinical practices (cardiothoracic & vascular surgery, general surgery, orthopedics & spine surgery, interventional radiology/cardiology, etc.). Learn more at www.medtechinsight.com.