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The U.S. Food and Drug Administration on March 30 expanded its approved use of the CoreValve transcatheter aortic-valve replacement (TAVR) system to include patients who already have undergone aortic valve replacement and need a second valve replacement done as a valve-in-valve placement.
With this action, CoreValve became the first TAVR system to receive U.S. approval for valve-in-valve use. The CoreValve System received FDA approval for TAVR performed on native aortic valves in January 2014 in patients at “extreme risk,” and in June 2014 for those at “high risk,” for surgical aortic valve replacement.* Valve-in-valve TAVR is only feasible in patients with a failing bioprosthetic aortic valve: It is not an option for patients with a failing mechanical aortic valve.
“The CoreValve System offers a less-invasive treatment option for a significant number of patients with failed tissue aortic valves whose medical teams determine that the risks associated with repeat open-heart surgery are high or extremely high,” Dr. William H. Maisel, deputy center director for science and chief scientist in the FDA’s Center for Devices and Radiological Health, said in a written statement. “The approval is an important expansion of the authorized use of the transcatheter aortic valve replacement technology.”
The CoreValve, which is designed to sit in a supra-annular location 12 mm above the aortic valve annulus, is well suited for valve-in-valve replacement because the only portion of the CoreValve that actually fills the annular space and the ring of the existing valve is the CoreValve’s sealer. This results in a tight seal that produces less paravalvular leak than when the sealer sits in a native annulus that is often deformed with calcium, noted Dr. Michael J. Reardon, professor of cardiothoracic surgery at Methodist Hospital in Houston.
In addition, because the sealer exerts pressure on the old valve ring in the annulus instead of on myocardium, placing the CoreValve as a valve-in-valve produces much less conduction disruption and results in fewer patients who need a pacemaker following TAVR, he said.
The CoreValve as a valve-in-valve “works quite well, and is not hard to position,” said Dr. Reardon, who added that he has now performed several valve-in-valve TAVRs using the CoreValve.
Similar TAVR procedures are usually not possible using the balloon-expandable SAPIEN System because the SAPIEN valve is designed to sit directly in the annulus and, in most patients, the existing valve ring does not provide enough space to accommodate a SAPIEN valve.
Dr. Reardon anticipates that many U.S. patients now in their 80s with a failing bioprosthetic aortic valve will be interested in nonsurgical TAVR replacement. These patients often do not want conventional open-heart surgery, he said in an interview.
To evaluate the safety and efficacy of the CoreValve System for aortic valve-in-valve replacement, the FDA reviewed clinical data collected from a U.S. clinical trial with 143 patients, an agency representative said in the statement. In the clinical trial, the estimated rate of 30-day survival without major stroke was 96%, and 89% after 6 months. “This compares well to the corresponding rates reported previously for trial participants who received the same device to replace their own, native diseased or damaged aortic valve,” the agency’s statement said.
According to the agency, aortic valve-in-valve use of the CoreValve System should be limited to patients who need replacement of a failed tissue aortic valve but are at extreme or high risk of death or serious complications from traditional open-heart surgery. A decision as to whether the product and procedure are appropriate for a patient “should involve careful evaluation by the patient’s heart medical team, including a cardiologist and a cardiac surgeon.”
The FDA said that the CoreValve System should not be used in patients who have any infection, have a mechanical aortic heart valve, cannot tolerate anticoagulant drugs, or have sensitivity to titanium, nickel, or contrast media.
Dr. Maisel had no disclosures. Dr. Reardon has served as an advisor to Medtronic, the company that markets the CoreValve.
On Twitter @mitchelzoler
*Correction, 4/1/2015: An earlier version of this article misstated the device’s approval history.
The U.S. Food and Drug Administration on March 30 expanded its approved use of the CoreValve transcatheter aortic-valve replacement (TAVR) system to include patients who already have undergone aortic valve replacement and need a second valve replacement done as a valve-in-valve placement.
With this action, CoreValve became the first TAVR system to receive U.S. approval for valve-in-valve use. The CoreValve System received FDA approval for TAVR performed on native aortic valves in January 2014 in patients at “extreme risk,” and in June 2014 for those at “high risk,” for surgical aortic valve replacement.* Valve-in-valve TAVR is only feasible in patients with a failing bioprosthetic aortic valve: It is not an option for patients with a failing mechanical aortic valve.
“The CoreValve System offers a less-invasive treatment option for a significant number of patients with failed tissue aortic valves whose medical teams determine that the risks associated with repeat open-heart surgery are high or extremely high,” Dr. William H. Maisel, deputy center director for science and chief scientist in the FDA’s Center for Devices and Radiological Health, said in a written statement. “The approval is an important expansion of the authorized use of the transcatheter aortic valve replacement technology.”
The CoreValve, which is designed to sit in a supra-annular location 12 mm above the aortic valve annulus, is well suited for valve-in-valve replacement because the only portion of the CoreValve that actually fills the annular space and the ring of the existing valve is the CoreValve’s sealer. This results in a tight seal that produces less paravalvular leak than when the sealer sits in a native annulus that is often deformed with calcium, noted Dr. Michael J. Reardon, professor of cardiothoracic surgery at Methodist Hospital in Houston.
In addition, because the sealer exerts pressure on the old valve ring in the annulus instead of on myocardium, placing the CoreValve as a valve-in-valve produces much less conduction disruption and results in fewer patients who need a pacemaker following TAVR, he said.
The CoreValve as a valve-in-valve “works quite well, and is not hard to position,” said Dr. Reardon, who added that he has now performed several valve-in-valve TAVRs using the CoreValve.
Similar TAVR procedures are usually not possible using the balloon-expandable SAPIEN System because the SAPIEN valve is designed to sit directly in the annulus and, in most patients, the existing valve ring does not provide enough space to accommodate a SAPIEN valve.
Dr. Reardon anticipates that many U.S. patients now in their 80s with a failing bioprosthetic aortic valve will be interested in nonsurgical TAVR replacement. These patients often do not want conventional open-heart surgery, he said in an interview.
To evaluate the safety and efficacy of the CoreValve System for aortic valve-in-valve replacement, the FDA reviewed clinical data collected from a U.S. clinical trial with 143 patients, an agency representative said in the statement. In the clinical trial, the estimated rate of 30-day survival without major stroke was 96%, and 89% after 6 months. “This compares well to the corresponding rates reported previously for trial participants who received the same device to replace their own, native diseased or damaged aortic valve,” the agency’s statement said.
According to the agency, aortic valve-in-valve use of the CoreValve System should be limited to patients who need replacement of a failed tissue aortic valve but are at extreme or high risk of death or serious complications from traditional open-heart surgery. A decision as to whether the product and procedure are appropriate for a patient “should involve careful evaluation by the patient’s heart medical team, including a cardiologist and a cardiac surgeon.”
The FDA said that the CoreValve System should not be used in patients who have any infection, have a mechanical aortic heart valve, cannot tolerate anticoagulant drugs, or have sensitivity to titanium, nickel, or contrast media.
Dr. Maisel had no disclosures. Dr. Reardon has served as an advisor to Medtronic, the company that markets the CoreValve.
On Twitter @mitchelzoler
*Correction, 4/1/2015: An earlier version of this article misstated the device’s approval history.
The U.S. Food and Drug Administration on March 30 expanded its approved use of the CoreValve transcatheter aortic-valve replacement (TAVR) system to include patients who already have undergone aortic valve replacement and need a second valve replacement done as a valve-in-valve placement.
With this action, CoreValve became the first TAVR system to receive U.S. approval for valve-in-valve use. The CoreValve System received FDA approval for TAVR performed on native aortic valves in January 2014 in patients at “extreme risk,” and in June 2014 for those at “high risk,” for surgical aortic valve replacement.* Valve-in-valve TAVR is only feasible in patients with a failing bioprosthetic aortic valve: It is not an option for patients with a failing mechanical aortic valve.
“The CoreValve System offers a less-invasive treatment option for a significant number of patients with failed tissue aortic valves whose medical teams determine that the risks associated with repeat open-heart surgery are high or extremely high,” Dr. William H. Maisel, deputy center director for science and chief scientist in the FDA’s Center for Devices and Radiological Health, said in a written statement. “The approval is an important expansion of the authorized use of the transcatheter aortic valve replacement technology.”
The CoreValve, which is designed to sit in a supra-annular location 12 mm above the aortic valve annulus, is well suited for valve-in-valve replacement because the only portion of the CoreValve that actually fills the annular space and the ring of the existing valve is the CoreValve’s sealer. This results in a tight seal that produces less paravalvular leak than when the sealer sits in a native annulus that is often deformed with calcium, noted Dr. Michael J. Reardon, professor of cardiothoracic surgery at Methodist Hospital in Houston.
In addition, because the sealer exerts pressure on the old valve ring in the annulus instead of on myocardium, placing the CoreValve as a valve-in-valve produces much less conduction disruption and results in fewer patients who need a pacemaker following TAVR, he said.
The CoreValve as a valve-in-valve “works quite well, and is not hard to position,” said Dr. Reardon, who added that he has now performed several valve-in-valve TAVRs using the CoreValve.
Similar TAVR procedures are usually not possible using the balloon-expandable SAPIEN System because the SAPIEN valve is designed to sit directly in the annulus and, in most patients, the existing valve ring does not provide enough space to accommodate a SAPIEN valve.
Dr. Reardon anticipates that many U.S. patients now in their 80s with a failing bioprosthetic aortic valve will be interested in nonsurgical TAVR replacement. These patients often do not want conventional open-heart surgery, he said in an interview.
To evaluate the safety and efficacy of the CoreValve System for aortic valve-in-valve replacement, the FDA reviewed clinical data collected from a U.S. clinical trial with 143 patients, an agency representative said in the statement. In the clinical trial, the estimated rate of 30-day survival without major stroke was 96%, and 89% after 6 months. “This compares well to the corresponding rates reported previously for trial participants who received the same device to replace their own, native diseased or damaged aortic valve,” the agency’s statement said.
According to the agency, aortic valve-in-valve use of the CoreValve System should be limited to patients who need replacement of a failed tissue aortic valve but are at extreme or high risk of death or serious complications from traditional open-heart surgery. A decision as to whether the product and procedure are appropriate for a patient “should involve careful evaluation by the patient’s heart medical team, including a cardiologist and a cardiac surgeon.”
The FDA said that the CoreValve System should not be used in patients who have any infection, have a mechanical aortic heart valve, cannot tolerate anticoagulant drugs, or have sensitivity to titanium, nickel, or contrast media.
Dr. Maisel had no disclosures. Dr. Reardon has served as an advisor to Medtronic, the company that markets the CoreValve.
On Twitter @mitchelzoler
*Correction, 4/1/2015: An earlier version of this article misstated the device’s approval history.
