The Fridley, Minn.-based medtech giant touted the approval as the first for any commercially available LVAD in the US, and said that the clearance came based on data from the Lateral clinical trial of the device.
The 144-patient trial met its primary endpoint of non-inferiority, with data indicating an 88.1% rate of survival at six months free from disabling stroke or device explant or exchange due to malfunction. Results also indicated a reduction in hospital stay length, down from an average of 26.1 days to 18 days, Medtronic said.
Overall survival amongst patients who underwent a thoracotomy-based HVAD implantation was 88.8% at one year, Medtronic said.
“We have demonstrated that a thoracotomy is a safe and effective implant technique for the HVAD system, which gives physicians added flexibility in treating a broad range of patients. Implanting the HVAD via thoracotomy preserves the chest for a subsequent procedure that patients may need, such as a heart transplant. It also has been shown to result in shorter hospital stays,” Lateral trial principal investigator Dr. Edwin McGee Jr. of the Loyola University Medical Center said in a prepared statement.
The company said that along with the approval, it has released tools designed to assist specifically with the thoracotomy implantation approach.
“The thoracotomy approach showed significant improvements in patients’ quality of life and functional capacity, supported by strong safety and effectiveness data from the study. Further, the added flexibility for implant approach offers a unique advantage of the HVAD System,” Medtronic cardiac & vascular group heat failure biz GM Dr. David Steinhaus said in a press release.
Last month, Medtronic said it won expanded FDA 510(k) clearance for its Kyphon HV-R bone cement designed for the fixation of pathological fractures of the sacral vertebral body.