FDA clears new stent-based coronary thrombectomy system
The U.S. Food and Drug Administration (FDA) has granted 510(k) market clearance to the enVast mechanical thrombectomy system from Texas-based Vesalio.
The company said the system offers a new approach to clot capture and the removal of large thrombus burden (LTB) in patients undergoing primary percutaneous coronary intervention (PCI). Thrombectomy is used in the coronary arteries to quickly remove clots to restore blood flow following a heart attack to minimizing myocardial damage.
"With FDA clearance and the upcoming U.S. launch of enVast, we are proud to introduce a device that we truly believe redefines coronary thrombectomy," Steve Rybka, CEO of Vesalio, said in a statement. "Clinical experience internationally has consistently demonstrated its safety and effectiveness in managing complex LTB situations."
The system's proprietary Drop Zone technology uses a stent-based clot capture architecture to securely engage and remove a variety of coronary clots. This includes soft, fragment-prone thrombi and dense fibrin-rich thrombi that are often resistant to aspiration.
The new system joins Vesalio's thrombectomy portfolio of devices for various anatomy, including the NeVa and pVasc platforms for use in the brain and peripheral anatomy.
The enVast device previously received CE mark clearance. It is now the first Vesalio offering to gain regulatory approvals in both the United States and Europe.
Dave Fornell has covered healthcare for more than 17 years, with a focus in cardiology and radiology. Fornell is a 5-time winner of a Jesse H. Neal Award, the most prestigious editorial honors in the field of specialized journalism. The wins included best technical content, best use of social media and best COVID-19 coverage. Fornell was also a three-time Neal finalist for best range of work by a single author. He produces more than 100 editorial videos each year, most of them interviews with key opinion leaders in medicine. He also writes technical articles, covers key trends, conducts video hospital site visits, and is very involved with social media. E-mail: [email protected]