Medtronic reports 88.1% ulcer healing in two‑year VenaSeal study
The 125-patient single-arm study had no control group, while Medtronic says U.S. payer coverage reaches 96% of commercial and Medicare insured lives.
Adrian Kessler
An 88.1 per cent ulcer-healing rate through two years gave Medtronic plc NYSEMDT fresh clinical evidence for VenaSeal on Saturday, as the company reported wider U.S. insurance coverage for the vein-closure device. Its Oct. 3 release put coverage at 96 per cent of commercially and Medicare insured lives.
The figure comes from 24-month follow-up in a prospective, single-arm study of 125 people with active venous leg ulcers. It is a cumulative healing rate; the ulcer cohort had no control group or treatment-versus-control p value.
Medtronic is an Ireland-headquartered medical technology company whose cardiovascular business sells devices for superficial venous disease worldwide.
On Friday, Medtronic shares closed at US$86.38 on the New York Stock Exchange at 4:00:04 p.m. EDT NYSEMDT. The announcement came after that close, leaving its market reaction for the next trading session.
The Ulcer Study Has No Control Arm
In Medtronic's study description, time to ulcer healing is the primary endpoint for patients with active ulcers. Median time to healing was 92 days in the Oct. 3 readout, a measure of how long treated patients waited for their wounds to close.
The company also reported a 22.9 per cent cumulative incidence of recurrence after initial healing, leaving 77.1 per cent free of recurrence through 24 months. Patients spent an average of 487 days without ulcers after healing; anatomic closure was 78 per cent through 24 months.
Medtronic said symptoms and quality-of-life scores improved from baseline. Those changes were measured within the treated group; the study cannot establish whether VenaSeal heals ulcers faster than another procedure in patients with active ulcers.
For safety, Medtronic reported no new related VenaSeal-specific adverse or serious adverse events between months six and 24. An independent committee reviewed safety events through month 12, and an independent wound laboratory confirmed ulcer healing, according to the company.
"Based on these findings, it is evident that the VenaSeal system is an appropriate, safe, and effective treatment for venous leg ulcers, the most advanced phase of superficial venous disease," principal investigator Manjit Gohel said in Medtronic's Oct. 3 release.
The investigator's assessment sits beside the study design. Medtronic's other Spectrum studies compare VenaSeal with thermal ablation or surgical stripping in less advanced disease, but the active-ulcer study followed VenaSeal recipients alone. The Oct. 3 release did not give a confidence interval for its healing estimate.
Medtronic Reports Broader U.S. Payer Coverage
Medtronic said VenaSeal is covered by all major U.S. commercial payers, reaching 96 per cent of commercially and Medicare insured lives. That describes insurance coverage, rather than the number of procedures performed; the Oct. 3 release did not disclose VenaSeal revenue or forecast a volume increase.
The company says the system is available in 70 countries, including the United States. The release describes an established product gaining follow-up evidence and wider insurance coverage, without reporting a new FDA approval tied to these results.
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Among listed medical-device companies, Boston Scientific Corporation NYSEBSX provides a broad market peer, though it was not a comparator in Medtronic's ulcer study. On Friday, its shares closed at US$42.60 on the NYSE at 4:00:04 p.m. EDT NYSEBSX. That close also predates Medtronic's Saturday announcement.
Trading on Monday, Oct. 5, will provide the first quoted response to the ulcer data and coverage claim. Medtronic's Oct. 3 release sets no calendar date for another Spectrum readout.
