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Comments sought on CMS proposed coverage expansion for carotid stenting
SVS members are encouraged to submit comments—due Aug. 10—to the Centers for Medicare & Medicaid Services (CMS) on its proposed national coverage determination on percutaneous transluminal angioplasty (PTA) of the carotid artery concurrent with stenting. The move would expand coverage…
Endologix announces first patients treated with the Detour system
Endologix has shared in a press release that the first patients underwent percutaneous transmural arterial bypass (PTAB) using the Detour system since Food and Drug Administration (FDA) approval of the system was granted. PTAB with the Detour system treats complex peripheral…
Long-awaited FDA update finds data do not support excess mortality risk for paclitaxel-coated devices
[vc_row][vc_column][vc_column_text] In a letter to healthcare providers dated July 11, 2023, the Food and Drug Administration (FDA) communicates that the risk of mortality associated with paclitaxel-coated devices to treat peripheral arterial disease (PAD) is no longer supported based on data…
Surmodics receives FDA approval for the SurVeil drug-coated balloon
Surmodics has announced the receipt of Food and Drug Administration (FDA) approval for the SurVeil drug-coated balloon (DCB). A company press release notes that the SurVeil DCB may now be marketed and sold in the U.S. to physicians for percutaneous…
FDA approves study of ZFEN+ for treatment of aortic aneurysms
The Food and Drug Administration (FDA) has granted approval for Cook Medical to initiate an investigational device exemption (IDE) study on the Zenith fenestrated+ endovascular graft (ZFEN+). The clinical study will assess the safety and effectiveness of the ZFEN+ in…
Two-year DETOUR2 study results presented at VAM 2023
Endologix has announced the 24-month results of the DETOUR2 study, presented at VAM 2023, the annual meeting of the Society for Vascular Surgery (SVS), by one of the study’s principal investigators, Sean Lyden, MD, chairman of vascular surgery at the…
FDA seeks to ‘modernize’ clinical trials with new draft guidance
The Food and Drug Administration (FDA) has released draft guidance with updated recommendations for good clinical practices (GCPs) aimed at modernizing the design and conduct of clinical trials. In a statement, the regulator said that the updates are intended to…
On 45th anniversary, CX Symposium chairman credits Chicago vascular surgical tandem for enduring success
The occasion of a seminal meeting held in Chicago by former Society for Vascular Surgery (SVS) Presidents John J. Bergan, MD, and James S.T. (Jimmy) Yao, MD, played a central role in the formation of the world-renowned Charing Cross (CX)…
Getting medical devices to market: The future might not be now, says regulatory expert
The development of medical devices in the vascular space faces increasing challenges amid moves afoot at the Food and Drug Administration (FDA), according to a leading regulatory expert in the field. Among the developmental vehicles currently caught in the crosshairs…
Surmodics provides regulatory update related to FDA premarket approval application for SurVeil
Surmodics recently announced it has received a letter from the Food and Drug Administration (FDA) related to its premarket approval (PMA) application for the SurVeil drug-coated balloon (DCB). In the letter, the FDA indicated that the application is not currently…