Technology | March 31, 2015

FDA Expands Use of CoreValve for Aortic Valve-in-Valve Replacement

Device is first of its kind for this use and eliminates need for open heart surgery

Corevalve, VIV, valve in valve, FDA

The Medtronic CoreValve TAVR device.

March 31, 2015 — The U.S. Food and Drug Administration (FDA) expanded the approved use of the CoreValve self-expanding transcatheter aortic valve replacement (TAVR) system to treat certain patients who have previously had a surgically implanted tissue aortic valve replacement and are in need of a second one. This is the first transcatheter heart valve approved in the United States for valve-in-valve procedures in both high and extreme risk patients who have limited options or may otherwise go untreated.

Each year, approximately 200,000 people worldwide receive surgical aortic valves, which typically last 15 years or more.[1]  When a surgical valve degenerates over time, patients may require another valve replacement. However, some patients are too sick or frail for a second open-heart surgery and the transcatheter valve-in-valve (VIV) procedure may now provide them with a new treatment option.

 
“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,” said William Maisel, M.D., deputy center director for science and chief scientist in the FDA’s Center for Devices and Radiological Health. “The approval is an important expansion of the authorized use of the transcatheter aortic valve replacement technology.”
 
Valve-in-Valve Procedures
During the VIV procedure, the CoreValve is placed inside a failing surgical heart valve with an inner diameter from 17-29 mm through a low-profile, 18 French delivery catheter, which is approved for use with all four CoreValve sizes (23, 26, 29 and 31 mm), as well as three delivery approaches (transfemoral, subclavian and direct aortic). The CoreValve is then released from the end of the catheter and expands on its own so it anchors to the old valve. Once the device is in place, it opens and closes properly, restoring the aortic valve function.
 
The CoreValve is an artificial heart valve made of tissue obtained from the heart of a pig. For support, it is attached to a flexible, self-expanding metal frame made of nickel-titanium alloy. It is engineered with a supra-annular valve design, which helps maximize blood flow for patients whose artificial heart valves have shown either stenosis, regurgitation, or both.
 
Clinical Data
To evaluate the safety and efficacy of the CoreValve system for aortic VIV replacement, the FDA reviewed clinical data collected from a clinical trial conducted in the United States of 143 participants. Outcomes from an Expanded Use Study, an observational arm of the CoreValve U.S. Pivotal Trial, demonstrated low rates of mortality and stroke (for a combined rate of 4.2 percent at 30 days and 10.7 percent at six months) and significant improvements in hemodynamics and quality of life in patients with failed surgical heart valves. Results from the largest global VIV registry also showed the VIV approach resulted in considerable hemodynamic improvements, including a decrease in blood flow resistance. In this registry, positive procedural outcomes were maintained at one year follow-up with 89 percent survival, which was comparable with other non-VIV TAVR studies.[2]  The data compares well to the corresponding rate reported previously for trial participants who received the same device to replace their own, native diseased or damaged aortic valve.
 
The major risks observed in the clinical trial included death, stroke, acute kidney injury, heart attack, bleeding, complications with the arteries used to insert the valve and the need for a permanent pacemaker. Bleeding and major complications with the arteries were the most frequently observed early adverse events. Medtronic, the manufacturer of the CoreValve System, will continue to follow study participants up to five years in a required post-market study to assess the long-term performance of the device.
 
FDA Indications
The FDA said the aortic VIV use of the CoreValve 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. The decision regarding whether the product and procedure is appropriate for a particular patient should only be made after careful evaluation by the patient’s heart medical team, including a cardiologist and a cardiac surgeon. The CoreValve System should not be used in patients who have any infection; have a mechanical aortic heart valve; cannot tolerate blood-thinning medicines; or have sensitivity to titanium, nickel or contrast media.
 
The FDA previously approved the CoreValve in 2014 to treat patients whose own aortic valve has become severely narrowed as a result of aortic stenosis and who are considered to be at extreme risk for surgical aortic valve replacement. Last June this was expanded to include high-risk sugical patients. The system received European CE mark for VIV procedures in May 2013.  The CoreValve system has been implanted in more than 75,000 patients in more than 65 countries since receiving CE mark in 2007.
 
For more information: www.medtronic.com
 
References:
1. Brown JM et al. The Journal of Thoracic and Cardiovascular Surgery. V.137; No.1; 1/09; p82
2. Dvir, D. et al. “Transcatheter Aortic Valve Replacement for Degenerative Bioprosthetic Surgical Valves: Results From the Global Valve-in-Valve Registry.” Circulation. October 2012.
 

Related Content

Mobility May Predict Elderly Heart Attack Survivors' Repeat Hospital Stays
News | Cath Lab | April 23, 2019
Determining which elderly heart attack patients take longer to stand from a seated position and walk across a room may...
FDA Releases New Guidance on Medical Devices Containing Nitinol
News | Cath Lab | April 18, 2019
April 18, 2019 — The U.S.
Angiography shows a stenotic lesion in the mid right coronary artery, undilatable by standard high-pressure balloon angioplasty (inset, arrowheads). (B) Optical coherence tomography (OCT) cross-sectional (top) and longitudinal (bottom) images acquired before IVL and coregistered to the OCT lens (arrow in A) demonstrate severe near-circumferential calcification in the area of the stenosis. (C) Angiography demonstrates improvement in the area of stenosis after IVL lithoplasty.

Figure 2: Angiography demonstrates a stenotic lesion in the mid right coronary artery, undilatable by standard high-pressure balloon angioplasty (inset, arrowheads). (B) Optical coherence tomography (OCT) cross-sectional (top) and longitudinal (bottom) images acquired before IVL and coregistered to the OCT lens (arrow in A) demonstrate severe near-circumferential calcification (double-headed arrow) in the area of the stenosis. (C) Angiography demonstrates improvement in the area of stenosis after IVL (inset; note the cavitation bubbles generated by IVL [black arrows]). (D) OCT cross-sectional (top) and longitudinal (bottom) images acquired post-IVL and coregistered to the OCT lens (white arrow in C) demonstrate multiple calcium fractures and large acute luminal gain. (E) Angiography demonstrates complete stent expansion with the semicompliant stent balloon (inset) without the need for high-pressure noncompliant balloon inflation. (F) OCT cross-sectional (top) and longitudinal (bottom) images acquired post-stenting and coregistered to the OCT lens (arrow in E) demonstrate further fracture displacement (arrow), with additional increase in the acute area gain (5.17 mm2), resulting in full stent expansion and minimal malapposition.

Feature | Cath Lab | April 15, 2019 | Dean Kereiakes, M.D., FACC, FSCAI, and Jonathan Hill, M.D., DISRUPT CAD III Co-Principal Investigators
Over the last 40 years, despite multiple advancements in percutaneous coronary interventions, calcified lesions remai
BIOTRONIK’s PK Papyrus covered coronary stent. The stent ius used in emergency coronary artery dissections to repair the vessel wall.
Technology | Cath Lab | April 15, 2019
April 15, 2019 — Biotronik began its U.S.
Providing Follow-Up Care After Heart Attack Helps Reduce Readmissions, Deaths
News | Cath Lab | April 09, 2019
A program designed to help heart attack patients with the transition from hospital to outpatient care can reduce...
TherOx Receives FDA Approval for SuperSaturated Oxygen Therapy
Technology | Cath Lab | April 08, 2019
TherOx Inc. announced that the U.S. Food and Drug Administration (FDA) granted premarket approval for its...
Cook Medical Recalls Transseptal Needle Due to Risk of Detached Plastic Fragments
News | Cath Lab | March 20, 2019
March 20, 2019 — Cook Medical is recalling one lot of its...
DABRA Excimer Laser System Demonstrates Success in Treating PAD
News | Cath Lab | February 27, 2019
Ra Medical Systems Inc. announced a 98 percent success rate in the results from a 52-patient study using the company’s...
Edwards Lifesciences Recalls Swan-Ganz hemodynamic catheters.
Feature | Cath Lab | February 06, 2019
Edwards Lifesciences is recalling its 131F7, 131F7J, 131F7P, 131VF7P, 151F7 Swan-Ganz Thermodilution Catheters manufa
Scientists Discover New Heart Attack Repair Pathway

A macrophage immune cell, with a dead cell (pink) that has been eaten, and a mitochondrion (green) between the dead cell and the nucleus. The study’s findings indicate that what the macrophage eats is taken up by the mitochondrion, which in turn communicates with the nucleus to activate the macrophage to promote tissue repair. Image courtesy of Northwestern Medicine.

News | Cath Lab | January 30, 2019
Northwestern Medicine scientists have discovered a novel signaling pathway that promotes healing after a heart attack....
Overlay Init