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FDA clears first sirolimus‑based drug‑eluting balloon for in‑stent restenosis

NEWZA Editorial Team•

⚡ Key Financial Takeaways

  • FDA has cleared the SELUTION SLR balloon, the first sirolimus‑based drug‑eluting balloon in the U.S.
  • The approval was based on the SELUTION4ISR trial, involving over 400 patients across 48 sites in the U.S., Canada, Brazil and Europe.
  • The balloon delivers sirolimus for about 90 days without leaving a permanent implant behind.
  • Cordis acquired MedAlliance, the developer of the technology, in October 2023 for $1.135 billion.
  • A separate U.S. trial with 960 patients on de‑novo lesions is underway and may support a second FDA submission.

💡 Why It Matters

In‑stent restenosis affects about 10% of the roughly one million percutaneous coronary interventions performed annually in the U.S. The new sirolimus‑based balloon provides clinicians with a non‑stent option that may lower restenosis rates and improve long‑term vessel patency, potentially changing standard care for a common interventional cardiology problem.

FDA Approval Marks Milestone The U.S. Food and Drug Administration has granted clearance to Cordis’ SELUTION SLR drug‑eluting balloon for the treatment of coronary in‑stent restenosis. This device is the first to use sirolimus, a potent anti‑proliferative agent, in a balloon‑based format approved in the United States.

Clinical Evidence Underpins Decision The approval followed the SELUTION4ISR trial, a randomised, multicentre study that enrolled more than 400 patients at 48 sites across North America, South America, Europe and Canada. The balloon met its primary non‑inferiority endpoint against standard‑of‑care treatment at 12 months, a key metric for interventional cardiology. Worldwide, the device has now been used in over 5,000 patients, with more than 250,000 treated globally.

Cordis' Strategic Move Cordis, which acquired MedAlliance in October 2023 for $1.135 billion, now owns the Sustained Limus Release technology that delivers sirolimus over roughly 90 days without leaving a permanent implant. The company has also completed enrolment in a separate U.S. trial involving 960 patients, testing the balloon on de‑novo lesions in small coronary vessels. The results of that study are expected to support a second FDA submission.

Future Trials and Market Outlook With the FDA clearance, American physicians now have a sirolimus‑based option in addition to the existing paclitaxel‑coated balloon. The upcoming trial on de‑novo lesions could broaden the device’s indications further. Cordis’ global presence in more than 65 countries positions it to capture a significant share of the in‑stent restenosis market, which accounts for roughly one in ten percutaneous coronary interventions in the U.S. each year.

Industry Reactions Amit Bohora, co‑founder of MedAlliance, described the decision as a “proud moment” that validates years of research into sustained sirolimus delivery without a permanent implant. Dr. Praveen Chandra, principal investigator of the first‑in‑human trial, called the approval a “historic vindication” of the underlying science.

The clearance is expected to influence treatment patterns for patients who experience restenosis after stent placement, offering a stent‑free alternative that could reduce long‑term complications associated with metal implants.

🏛️ Background & Context

Percutaneous coronary intervention (PCI) is a routine procedure to open narrowed coronary arteries. While stents reduce immediate blockage, they can later narrow again, a condition known as in‑stent restenosis. Prior to this approval, only paclitaxel‑coated balloons were available in the U.S. for this indication.

👁️ What To Watch Next

The results of the 960‑patient U.S. trial on de‑novo lesions will be announced later this year and could lead to a second FDA submission, expanding the balloon’s approved uses.

Topics:#FDA#drug‑eluting balloon#sirolimus#Cordis#coronary artery disease
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