06.26.12
According to a report by the Millennium Research Group (MRG), The U.S. heart valve market will grow to $1.5 billion by 2016. In fact, medical market intelligence groups have been predicting a rise in sales in a variety of markets, particularly orthopedics and cardio, mostly due to an aging population and innovation. In the case of heart valves, MRG points to the introduction of transcatheter aortic valve replacement (TAVR) devices as the driver behind the growth.
TAVR is a procedure for select patients with severe symptomatic aortic stenosis (narrowing of the aortic valve opening) who are not candidates for traditional open chest surgery or are high-risk operable candidates.
Edwards Lifesciences’ Sapien heart valve, approved by the U.S. Food and Drug Administration in November 2011, will be an important driver of the market growth. It is the first transcatheter valve for aortic valve replacement for sale in the United States.
There have been some ripples in the water around the Sapien valves, however. Patients who used Sapien experienced double the stroke risk in the first 30 days after the implant procedure, compared with those who had open-heart surgery, according to a report released on June 11 by the FDA. If Sapien, which was approved in November for inoperable patients, is cleared as an alternative to surgery, FDA staff said long-term follow-up is warranted.
“Just last week the FDA’s Circulatory System Devices Panel voted for an expanded indication for Sapien,” said MRG Analyst Ian Swanson. “We had anticipated this approval, and factored it into our market predictions. With this potential approval Sapien could be used in the treatment of patients with symptomatic severe aortic stenosis who have high operative risk. Previously the device was restricted only to those who were not surgical candidates at all. We’ll see further expanded indications as the FDA becomes comfortable with the clinical picture for these devices.”
With expanded use indicated for the Sapien valve, the FDA will be reviewing the risks associated with such a new device that have significant caveats to its use.
Edwards expects to have the next-generation version of the Sapien valve, the Sapien XT, out before Medtronic has its first TAVR device, the CoreValve, on the market in 2014.
The aging population, while promising market growth, also poses negative pressures. As non-surgical valve replacement procedures become ubiquitous, surgical heart valve replacement will shrink. Paired with falling prices, surgical replacement heart valves will see a decline through 2016.
MRG is a subsidiary of Decision Resources Group, and is based in Toronto, Ontario, Canada. The company provides market intelligence for the medical technology industry.
TAVR is a procedure for select patients with severe symptomatic aortic stenosis (narrowing of the aortic valve opening) who are not candidates for traditional open chest surgery or are high-risk operable candidates.
Edwards Lifesciences’ Sapien heart valve, approved by the U.S. Food and Drug Administration in November 2011, will be an important driver of the market growth. It is the first transcatheter valve for aortic valve replacement for sale in the United States.
There have been some ripples in the water around the Sapien valves, however. Patients who used Sapien experienced double the stroke risk in the first 30 days after the implant procedure, compared with those who had open-heart surgery, according to a report released on June 11 by the FDA. If Sapien, which was approved in November for inoperable patients, is cleared as an alternative to surgery, FDA staff said long-term follow-up is warranted.
“Just last week the FDA’s Circulatory System Devices Panel voted for an expanded indication for Sapien,” said MRG Analyst Ian Swanson. “We had anticipated this approval, and factored it into our market predictions. With this potential approval Sapien could be used in the treatment of patients with symptomatic severe aortic stenosis who have high operative risk. Previously the device was restricted only to those who were not surgical candidates at all. We’ll see further expanded indications as the FDA becomes comfortable with the clinical picture for these devices.”
With expanded use indicated for the Sapien valve, the FDA will be reviewing the risks associated with such a new device that have significant caveats to its use.
Edwards expects to have the next-generation version of the Sapien valve, the Sapien XT, out before Medtronic has its first TAVR device, the CoreValve, on the market in 2014.
The aging population, while promising market growth, also poses negative pressures. As non-surgical valve replacement procedures become ubiquitous, surgical heart valve replacement will shrink. Paired with falling prices, surgical replacement heart valves will see a decline through 2016.
MRG is a subsidiary of Decision Resources Group, and is based in Toronto, Ontario, Canada. The company provides market intelligence for the medical technology industry.