Medtronic Inc. (NYSE:MDT) received approval from the Food & Drug Administration for its endovascular-based arortic anneurysm treatment.
The Fridley, Minn.-based company’s new Talent Thoracic stent graft with Captivia delivery system features a tip capture mechanism for controlled placement. The device treats thoracic aortic aneurysms, which are bulges in the aorta that can burst and lead to death.
During an aortic repair procedure with a stent graft, surgeons deploy the device via the femoral artery and expand it at the site of the aneurysm to create a new path for blood flow that reduces pressure on the aortic deformity and subsequently the risk of rupture, according to Medtronic.
The company said an estimated 60,000 people in the U.S. have a TAA and only about half are ever diagnosed due to lack of symptoms.
On Friday, the FDA classified Medtronic’s recall of its Octopus Nuvo tissue stabilizer device as a Class I recall.
Class I is the watchdog agency’s most serious recall status, applied when the FDA believes there is a risk that the product will cause serious injury or death.
Medtronic voluntarily recalled the device Sept. 14 because of the potential that a component could fracture during surgery and damage a patient’s heart. The company said it received two reports of device failure, but neither event resulted in permanent impairment or death.
The medical device giant said hospitals should immediately discontinue use of the device and return all unused Octopus Nuvo tissue stabilizer devices to Medtronic. All 571 Octopus Nuvo Tissue Stabilizer devices are affected, according Medtronic, but no other models in the Octopus family of products are affected by the recall.
Medtronic said healthcare providers with questions regarding the product should call their company representative or contact the CardioVascular Lifeline for technical services at 1-877-526-7890.
Medtronic also last week previewed its lead-less pacemaker at TEDMED.
The company has not been forthcoming with many details about the the device, but doctors can reportedly implant the device directly into the right ventricle of the heart.
Now, thanks to Engadget, potential customers get their first look at what Medtronic has been cooking up. The company debuted its wireless pacemaker at the TEDMED conference in San Diego. Dr. Stephen Osterle, senior vice president of medicine and technology, unveiled the device at the conference.
The capsule-like device is slightly bigger than a penny, much smaller than a regular pacemaker. Doctors apparently can control the device with a smart phone. The pacemaker has come a long way since the days of Medtronic founder Dr. Earl Baaken.
Implanting pacemakers without using wires could lower the cost of the surgery, industry analysts say. A pacemaker that small also would be easier to insert and consume less power. And Medtronic is working on shrinking it further, Engadget reports.
It doesn’t seem that long ago when medical device developers raced each other to make smaller and thinner wires. Now apparently, they’re just focusing on making the devices smaller.
Information from MedCity News was used in this report.