Medtronic (NYSE:MDT) said today it won CE Mark approval in the European Union for a less-invasive implant procedure for the HVAD system left ventricular assist device it acquired along with HeartWare in August.
The new implantation procedure uses a smaller incision than the previously cleared procedure, Fridley, Minn.-based Medtronic said, potentially lessening bleeding and related blood transfusions.
The newly cleared procedure could potentially reduce the development of right heart failure and could lead to shorter hospital stays, along with allowing for the area around the heart to remain largely intact to potentially preserve the sternum for future procedures or heart transplants, the company said.
“The HVAD System’s small size makes it well-suited for routine thoracotomy implantation. This less-invasive implant procedure potentially enables faster patient recovery compared to the traditional approach, which may help improve patient outcomes,” Dr. Jan Schmitto of Germany’s Hannover Medical School, who helped develop the new procedure, said in prepared remarks.
The company said it is currently performing an ongoing study of the thoracotomy HVAD procedure in Canada and the U.S., where it does not currently have approval.
“The HVAD System is the only full-support, centrifugal LVAD approved in Europe for thoracotomy implantation, providing clinicians with greater freedom to choose the best surgical technique for each patient. CE Mark for the thoracotomy procedure is a testament to the HVAD system’s flexibility and versatility, and may enable more patients to receive the life-sustaining benefit of the device for the treatment of advanced heart failure,” VP and Medtronic HF biz GM Dr. David Steinhaus said in a press release.
HeartWare is currently engaged in 2 ongoing recalls of its HVAD devices, which it originally announced in September. Earlier this month, the FDA released updated information on the Class I recalls, which affect a total of 4,669 units.
The 1st recall is over issues with loose power connectors, which may cause the rear portion of the pump’s driveline connector to become separated from the front portion. A loose connector could allow moisture to entire the controller and cause corrosion, which could cause electrical issues, reduced speaker volume and connection failures.
The 2nd recall is related to design flaws in the driveline connector of the device which connects the HVAD’s pump to the external controller and power source. The flaw could cause contamination of the driveline which can result in fluid and material entering the pump and causing electrical issues or pump stops.