#USA #Singapore #CE Mark #Spectrumedics #Sonico-CX

Spectrumedics Receives CE Mark Approval

Spectrumedics Medical has recently announced a significant milestone in its clinical journey with the approval of the CE mark for its Sonico-CX intravascular lithotripsy (IVL) system. This coveted certification indicates that the device meets the stringent safety, performance, and quality requirements set by the European Union (EU). Obtained from the internationally recognized notified body BSI, this approval is a testament to Spectrumedics' dedication to improving vascular therapies.

The Sonico-CX system consists of a specialized coronary IVL catheter matched with an accompanying lithotripsy generator. The device is designed specifically for treating calcified coronary lesions, enhancing patient outcomes and ensuring a safer procedure with its unique capabilities. With the CE mark acquisition, Spectrumedics is poised to expand its global footprint, which has already seen success in markets across Latin America and the Asia-Pacific region. The company now aims to embark on commercial launches in Europe and the Middle East.

Improving Treatment Options

The Sonico-CX system stands out as an innovative option to treat calcium deposits in coronary arteries. Using acoustic pressure waves, the device safely modifies superficial and deep calcified plaques, thus enhancing vascular compliance and promoting optimal stent implantation. This technology offers a circumferential energy delivery of 360° and can deliver up to 120 pulses through a catheter, improving treatment precision and patient outcomes.

Spectrumedics is actively working to expand their IVL catheter line, which includes a forward-firing IVL catheter specifically designed for narrow and resistant lesions. Additionally, plans are underway to broaden the application spectrum of their IVL catheters, offering treatments for valve indications and peripheral vascular calcification. These innovations aim to foster the adoption of advanced interventional solutions globally, ensuring patients have access to the best possible care.

Dr. Elynn Phang, founder and CEO of Spectrumedics, reflects on this achievement: "This success represents a significant step in our mission to expand global access to advanced IVL therapy. We look forward to collaborating with more physicians to provide faster, safer, and more effective treatment for patients facing complex calcification."

Benefits and Features of Sonico-CX

The Sonico-CX system showcases numerous design advancements aimed at improving both vascular compliance and procedural outcomes. The minimally invasive nature of IVL technology simplifies usage, yields a shorter learning curve, and presents broad applicability. These benefits contribute to a reduction in procedure-related complications and the need for follow-up interventions, significantly enhancing patient recovery experiences.

With its CE mark approval, Spectrumedics is on the path to revolutionizing treatment protocols for calcified vascular diseases, thereby addressing one of the pressing challenges in contemporary cardiovascular care. The drive to develop safer, more effective medical devices aligns with the ever-evolving demands of healthcare providers and patients alike.

About Spectrumedics Medical

Spectrumedics is an emerging global player in cardiovascular medical devices, committed to transforming treatment methodologies for patients suffering from calcified vascular diseases. With patented technology platforms, the company aims to redefine interventional care by offering safer, more effective, and accessible solutions to a growing health challenge.

As Spectrumedics sets its sights on the European and Middle Eastern markets, healthcare providers can expect innovative, advanced solutions that align with the highest standards of patient care. This commitment to excellence is not just a milestone; it’s the beginning of a transformed approach to treating complex vascular conditions.