Medtronic Wins FDA Clearance and CE Mark for Affera Prism-2 Software

The VIVA Foundation presented late-breaking clinical trial results at The VEINS 2026 conference. Key findings include 88.1% ulcer healing rate with Cyanoacrylate Closure (CAC) for C6 disease, 100% technical success for the VEnice device in treating venous incompetence, and favorable 30-day results for the Abre Venous Stent System. The RAPID-PE study showed promising interim results for on-the-table mechanically channeled thrombolysis in acute intermediate-risk pulmonary embolism.

Medtronic reported an 88.1% ulcer-healing rate over two years for its VenaSeal device, with 96% U.S. insurance coverage. The study involved 125 patients, showing a median healing time of 92 days and 77.1% recurrence-free rate. Medtronic shares closed at $86.38 on Friday, with market reaction pending.

Medtronic (MDT) announced AMA approval for new Category I CPT codes for its Altaviva and Symplicity Spyral devices. The company offers a 3.21% dividend yield, a 64% payout ratio, and a GF Value of $100.84. MDT's GF Score is 81, indicating strong financial health. Insider activity shows net selling, while institutional sentiment is mixed.

Medtronic (MDT) received Category I CPT code approvals for its Altaviva and Symplicity Spyral devices, effective January 2028. These codes, assigned by the AMA, indicate established procedures with clinical evidence. The Altaviva device treats urinary incontinence, while the Symplicity Spyral system addresses high blood pressure. According to the company, the approvals reflect clinical evidence and physician adoption.

Medtronic (MDT) received Category I CPT® codes for Altaviva™ and Symplicity Spyral™ systems, effective January 2028. These codes, replacing existing Category III codes, are permanent and indicate well-established procedures with robust clinical evidence. The Altaviva™ device treats urge urinary incontinence, while the Symplicity Spyral™ system addresses uncontrolled hypertension.

Medtronic (MDT) received FDA breakthrough designation for its In.Pact BTK drug-coated balloon, targeting arteries below the knee. The device will undergo a pivotal trial with 400 participants. No such products are currently available in the U.S. for this indication, according to the company.