#Singapore #IVL System #Spectrumedics #Sonico-CX

Spectrumedics Achieves CE Mark Approval for Sonico-CX Intravenous Lithotripsy System

Spectrumedics Medical has just announced a significant milestone in cardiac intervention technology: the receipt of a CE mark for its innovative intravascular lithotripsy system (IVL), the Sonico-CX. This approval, granted by the recognized certification body BSI, certifies that the Sonico-CX system complies with the stringent safety, performance, and quality requirements of the European Union's Medical Device Regulation (EU MDR).

Implications of CE Mark Approval

The CE mark is crucial as it opens the door for Spectrumedics to expand its reach within the European and Middle Eastern markets, following a successful introduction in Latin America and the Asia-Pacific region. With this new approval, Spectrumedics is determined to accelerate the rollout of its advanced solutions to treat calcified coronary lesions.

Dr. Elynn Phang, the Founder and CEO of Spectrumedics, expressed her enthusiasm about this achievement, stating, "This success is a pivotal step in our mission to enhance global access to advanced IVL therapy. We look forward to collaborating with medical professionals to provide faster, safer, and more effective treatment for patients with complex calcifications across the globe."

Understanding the Sonico-CX System

The Sonico-CX system is designed to treat calcified coronary lesions effectively by utilizing acoustic pressure waves, which modify both superficial and deep calcified plaques. This method improves vessel compliance and facilitates optimal stent implantation. Key features of the Sonico-CX include a 360° energy delivery mechanism, the ability to perform up to 120 impulses per catheter, a minimal crossing profile, and a selection of seven different balloon sizes ranging from 2.5 to 4.0 mm.

These design advancements aim to not only enhance procedural outcomes but also reduce the risk of complications and the likelihood of subsequent treatments, ultimately leading to improved patient results.

Future Opportunities and Innovations

Looking ahead, Spectrumedics plans to continue innovating its IVL pipeline. This includes developing a forward-looking IVL catheter designed specifically for difficult and non-passable lesions. Additionally, the company seeks to expand its IVL applications beyond coronary indications to encompass peripheral vascular calcifications and heart valve applications.

With a commitment to redefining interventional care, Spectrumedics is focused on delivering solutions that are safer, more effective, and more accessible to tackle one of the most complex and rapidly growing challenges in cardiovascular therapy.

In conclusion, the CE mark designation for the Sonico-CX marks a significant leap forward in the realm of intravascular lithotripsy, promising a future where patients suffering from calcified arterial diseases can expect enhanced treatment options and better outcomes in their healthcare journeys.