APAC medtech company scores TGA approval in heart disease

MedTech & Diagnostics News: An Asia Pacific medtech company has announced that its flagship drug-eluting stent (DES) has received regulatory approval from the Therapeutic Goods Administration (TGA) for the treatment of coronary artery disease. This significant milestone allows Indian-based Sahajanand Medical Technology (SMT) to broaden its presence in Australia’s healthcare market.

The Supraflex Cruz DES is engineered to deliver a potent combination of sirolimus and a biodegradable polymer, ensuring optimal drug release and promoting vessel healing. Its innovative design provides greater flexibility, minimises injury to the arterial wall, and accelerates endothelial healing, which ultimately contributes to improved patient outcomes.

Anil Suri, Head of APAC, SMT expressed his excitement about the TGA approval, saying “We are thrilled to receive TGA approval for Supraflex Cruz, which allows us to expand our footprint in Australia and provide patients and healthcare professionals with a superior solution for treating coronary artery disease. This approval highlights our commitment to bringing innovative, life-saving technologies to global markets.”

AA-Med is the sponsor of the medical device in Australia. The design of device also facilitates access to challenging and tortuous lesions, retaining the beneficial features of the previous Supra family of stents. These include thin struts, a unique blend of biodegradable polymers for drug delivery, high radial strength, and a low crossing profile. The size matrix for the Supraflex Cruz DES ranges from diameters of 2.0 to 4.5 mm and lengths from 8 to 48 mm.

Suri further added, “Supraflex Cruz offers exceptional acute performance and proven safety and efficacy. We are confident that it will make a significant impact on cardiovascular care in Australia, as it has in over 80+ countries globally, where it’s currently approved.”

In related news, SMT’s TUXEDO-2 trial is evaluating the safety and efficacy of percutaneous coronary intervention (PCI) with the company’s Supraflex Cruz drug-eluting stent (DES) in patients with diabetes and multivessel coronary artery disease (CAD) versus the Xience DES (Abbott Vascular). It is also evaluating outcomes of PCI compared with historical coronary artery bypass graft (CABG) data from the FREEDOM trial.

Preliminary results are expected to be presented at the Transcatheter Cardiovascular Therapeutics (TCT) Symposium in October 2025.

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