Stent maker Sahajanand Medical Technologies Faces Hurdle in European Market
This development comes after a prominent international regulatory body, reportedly suspended the CE certification for the stent, raising questions about its strut thickness and other parameters.
Surat : In a significant setback for Surat-based Sahajanand Medical Technologies (SMT), a leading coronary stent manufacturer, a message is doing rounds about Supraflex heart stent barred from sale in the European market. This development comes after a prominent international regulatory body, reportedly suspended the CE certification for the stent, raising questions about its strut thickness and other parameters.
Unconfirmed Sources claim that SMT compared Supraflex directly to a leading European marketing materials, prompting a lawsuit, alleging misleading and disparaging claims.
Responding to the development, a senior SMT official in Surat dismissed the lawsuit as a competitor’s attempt to boost sales. “This lawsuit is filed by a competitor who is trying to sell their stent business because of financial issues,” the official stated. They further clarified that production at SMT’s facilities in India remains unaffected.
Following the lawsuit and reported CE suspension, SMT is learnt to have removed CE markings and references to CE certification from its Supraflex stents. The Blunt Times has reached out to the European company but they refused to confirm stating that they have not filed any case against SMT.
The suspension of Supraflex’s CE certification is a major blow to SMT’s European ambitions. The European market represents a significant revenue opportunity for stent manufacturers, and this development could potentially impact SMT’s financial performance. Additionally, the lawsuit and regulatory action raise questions about the accuracy of claims made by SMT regarding its Supraflex stent.