Product News

Cardiovascular Systems announces US FDA 510(k) submission of Innova Vascular’s thrombectomy system

Cardiovascular Systems (CSI), recently acquired by Abbott, announced that Innova Vascular (Innova) has submitted a 510(k) premarket notification to the US Food and Drug Administration (FDA) for its thrombectomy devices intended to treat peripheral vascular disease.

CSI intends to acquire and commercialise each of the novel thrombectomy devices from Innova targeting peripheral vascular disease. Commercialisation of the thrombectomy devices will be complementary to CSI’s broader portfolio of advanced technologies used in the treatment of cardiovascular disease.

Sanjay Shrivastava, CEO of Innova, said: “The FDA submission of the thrombectomy devices for use in the peripheral vasculature marks an important milestone in our commitment to develop innovative technologies targeting large, underserved markets. We are excited to partner with CSI, which has been serving the interventional cardiology, interventional radiology, and vascular surgery communities that will be the primary users of this thrombectomy system.”

Pending regulatory clearance in the USA and completion of the acquisition of the first Innova system, CSI could begin to commercialise a portfolio of aspiration catheters and clot retrieval devices for use in peripheral vasculature in approximately six months. The portfolio and corresponding indications for use will be expanded to include the treatment of deep vein thrombosis and pulmonary embolism following completion of the respective clinical trials and subsequent 510(k) clearances. These trials are expected to begin enrolling later in 2023.

Endologix receives US FDA approval of PMA supplement for AFX2 system

Endologix recently announced that it has received US Food and Drug Administration (FDA) approval for a premarket approval (PMA) supplement relating to the AFX2 system.

According to a company press release, Endologix received approval to include an updated warning and the most contemporary clinical information in the labelling for the AFX2 system.

Clinical data added to the instructions for use (IFU) includes: final results from the five-year LEOPARD randomised controlled trial, and results from the recently published, independently performed, VQIVISION analysis on abdominal aortic aneurysm (AAA) endografts.

Endologix notes that in both reported studies, out to three years, the rates shown for rupture and reintervention are comparable between the AFX/AFX2 device cohort and endovascular aneurysm repair (EVAR) comparator devices.

Additionally, results from the LEOPARD study demonstrated no significant difference in aneurysmrelated mortality, all-cause mortality, rupture, secondary interventions, and Type I and Type III endoleaks between the AFX/AFX2 device cohort and the EVAR comparator devices.

Chocolate Touch drugcoated angioplasty

balloon for treatment of PAD receives FDA approval

Genesis MedTech Group announced that the US Food and Drug Administration (FDA) has approved the Chocolate Touch drug-coated balloon (DCB) percutaneous transluminal angioplasty (PTA) catheter, developed by TriReme Medical, for the treatment of patients with peripheral arterial disease (PAD) in the superficial femoral artery (SFA) and the popliteal artery.

The Chocolate Touch DCB was shown to have statistically superior patency and non-inferior safety at 12 months as compared with Lutonix DCB (BD) based on a head-tohead, randomised trial of patients with symptomatic femoropopliteal disease.

The Chocolate Touch showed statistically superiority in its primary efficacy endpoint of 12-month true DCB success—a measure of the target vessel remaining patent without the need for bail-out stenting. Primary patency by Kaplan-Meier (KM) estimate was 83.3% for the Chocolate Touch and 73.0% for Lutonix DCB at 12 months.

The primary safety endpoint of 12-month freedom from major adverse events (MAEs) was 88.9% for those treated with the Chocolate Touch versus 84.6% for Lutonix DCB.

AFX2

Additionally, Chocolate Touch results reported the lowest all-cause KM mortality value as compared to reported mortality for FDA-approved DCBs in pivotal studies. Mortality rates for Chocolate Touch using KM estimates at three years were 6.7% for the Chocolate Touch and 11.1% for the Lutonix DCB.