FDA Clears VCD Medical’s First US Vein-Closure Device

VCD Medical S.p.A., a privately held device maker based in Brescia, Italy, said 29 September 2026 that FDA granted 510(k) clearance for its VEnice Vein Closure Device — the company's first regulatory clearance in the United States. VEnice closes varicose veins mechanically, with an implanted clip, rather than with heat, adhesive, or chemical sclerosant. The clearance follows a US general-manager hire the company made in May, explicitly described at the time as preparation for an anticipated clearance. As of this writing, VCD Medical's own release is the only public account of the clearance.

A clip, not heat or glue

VEnice targets the same clinical problem as several existing vein-closure technologies — incompetent superficial and perforator veins behind varicose-vein disease — with a different mechanism. Thermal systems (radiofrequency or endovenous laser ablation) close the vein by heating it shut and generally require tumescent anesthesia, a ring of local anesthetic injected around the vein. Chemical and adhesive systems, such as Medtronic's VenaSeal, close the vein with an injected cyanoacrylate adhesive, avoiding tumescent anesthesia but introducing a permanent implant of a different kind. VCD Medical describes VEnice as purely mechanical: a handheld applicator with a 17-gauge needle and an integrated suture cutter deploys a pre-loaded implantable clip, under real-time ultrasound guidance, to compress and occlude the vein. “FDA clearance of VEnice represents a significant milestone for VCD Medical and marks an important step in our U.S. commercialization plans,” said Francesco Piccagli, PhD, chief executive officer of VCD Medical, in the announcement. “We developed VEnice to offer physicians a percutaneous closure technology platform that is easy and fast to use for immediately enhanced patient comfort.” The company's release cites varicose veins as affecting as many as 40 million Americans, with hundreds of thousands of procedures performed annually in the US — two separate figures the release does not merge into one claim. VCD Medical has not published an independent comparison of VEnice against VenaSeal or other mechanochemical systems such as ClariVein; its characterization of the device's advantages is, so far, its own.

A clearance the company had been building toward

VCD Medical hired Denna Babul, a 25-year veteran of vascular device commercialization at Abbott Vascular, Boston Scientific, and Cardiovascular Systems, as its general manager for the United States in May 2026 — a newly created role the company said at the time would “lead US market readiness activities as the company builds its organizational, clinical, regulatory, and commercial foundation ahead of anticipated regulatory clearance.” That clearance arrived four months later. “FDA clearance marks an exciting milestone for VCD Medical and opens the door to bringing VEnice to US physicians,” Babul said in the 29 September announcement. “We're excited to engage with the vascular community and introduce physicians to a new approach to superficial and perforator vein closure.” The company, founded in 2021 and advised through a stock-option plan put in place alongside a fourth funding round in May 2026, has not disclosed how much it has raised in total or when it expects VEnice to reach US physicians commercially. Its European regulatory status for the device is similarly unstated in this announcement; Regulatory News found evidence of an earlier European clinical study of a percutaneous vein-closure device combining clip deployment with sclerotherapy, associated with VCD Medical's co-founder, vascular surgeon Gastone Bergamaschi, but could not confirm that study used the VEnice brand name specifically, or confirm a CE Mark date. No independent trade-press coverage of the US clearance, and no public 510(k) number, had surfaced as of this writing.

Frequently asked questions

What did FDA clear?

VCD Medical's VEnice Vein Closure Device, cleared via 510(k) on 29 September 2026 — the company's first US clearance, covering percutaneous and surgical use in superficial and perforator veins.

How does VEnice work?

A pre-loaded implantable clip, deployed through a 17-gauge needle applicator under ultrasound guidance, mechanically compresses and occludes the vein — distinct from thermal (heat) or adhesive (glue) closure methods.

Is VEnice available in Europe?

Unconfirmed from the public record. There is evidence of an earlier European clinical study of a related device, but no confirmed CE Mark date or EU sales claim.

Is VCD Medical publicly traded?

No. It is privately held, closed a fourth funding round in May 2026 without disclosing the amount, and has not published a 510(k) number for this clearance.