FDA confirms recall after device left in patient’s body | Bleeding reversal agent pulled from market | ACC & AHA take on PAD

This is a Class I recall, which means the FDA believes these devices could cause a serious injury or death.

Massachusetts-based SpectraWAVE has gained considerable momentum in recent years, planting its flag in some of cardiology’s biggest trends. The company was co-founded by cardiologists and has already secured multiple FDA clearances.

Fogarty created many inventions that fundamentally changed cardiac surgical practice. He also received the Presidential Medal of Technology and Innovation from President Barack Obama in 2014.

The device at the heart of this transaction is the PerQseal Elite system, a fully bioabsorbable patch for percutaneous vessel closure. The technology has already gained key approvals in Europe. 

AstraZeneca has stopped selling Andexxa because randomized data suggested some patients may face an increased risk of certain adverse events. The company emphasized that it remains confident in the agent's abilities.

The ACC and AHA have published updated performance and quality measures focused on the diagnosis and management of peripheral artery disease. Several other specialty societies, including SCAI and SIR, also participated in the development of this new document.

Customers are urged to examine their inventory, quarantine any unused products and return them to the manufacturer. 

According to Gore, the newly approved device was built with conformability, strength and fracture resistance in mind. 

PAD in patients with diabetes is common and associated with an increased risk of several adverse events. A new guidance from the American College of Cardiology reviewed this topic at length, identifying areas where care needs to improve.

When the devices needed for a specific procedure were not available, a group of surgeons got creative. Their one-of-a-kind approach was a success, and the patient has experienced no complications.