News

MedAlliance SELUTION SLR Receives Coronary FDA IDE Approval

24th October 2022 – SELUTION SLR™, MedAlliance’s novel sirolimus-eluting balloon, has received FDA Investigational Device Exemption (IDE) approval to initiate its coronary pivotal clinical trial.  This is the first sustained limus release coronary drug eluting balloon (DEB) to receive FDA IDE approval for In-stent Restenosis (ISR) indication. The study has already begun enrollment in Europe.

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MedAlliance to be Acquired by Cordis

18 October 2022 – Swiss-based medical technology company MedAlliance has announced it has entered into an agreement with Cordis for an acquisition which includes an initial investment of $35M and upfront closing payment of $200M, regulatory achievement milestones of up to $125M and commercial milestones of up to $775M through 2029 for a total consideration of up to $1.135 Billion.

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First US Patient Enrolled in SELUTION SLR IDE Peripheral Study

22 August 2022 – The first US patient has been enrolled in the FDA SELUTION4BTK (Below-the-Knee) clinical trial evaluating SELUTION SLR™, MedAlliance’s novel sirolimus-eluting balloon.  This milestone follows Investigational Device Exemption (IDE) approval in the US in May 2022, with enrollment of the first patient occurring in Germany one week after approval.  

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MedAlliance’s SELUTION SLR™ Receives Second FDA IDE Approval

9 August 2022 – SELUTION SLR™, MedAlliance’s novel sirolimus-eluting balloon, has received conditional FDA Investigational Device Exemption (IDE) approval to initiate its pivotal clinical trial for the treatment of occlusive disease of the superficial femoral artery (SFA). This comes only a few months after the company received IDE approval for SELUTION SLR in the treatment of below-the-knee (BTK) indications (May 2022).

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