Draft:Spectrumedics Medical

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Spectrumedics Medical

Overview

Spectrumedics Medical is a medical device company specializing in intravascular lithotripsy (IVL) technology for the treatment of coronary and peripheral artery diseases. The company focuses on developing innovative, minimally invasive solutions to address vascular calcification, improving patient outcomes in interventional cardiology and peripheral interventions.

History

Spectrumedics Medical was founded in 2019 with the mission to advance intravascular lithotripsy technology as a safe and effective alternative to traditional atherectomy devices and cutting balloons. The company has since expanded its market presence in Southeast Asia, Latin America, and other emerging markets through strategic partnerships and regulatory approvals.

Products

SONICO-CX

The SONICO-CX is Spectrumedics Medical’s flagship IVL catheter system, designed to deliver controlled shockwave pulses to break down calcified plaque in coronary arteries.

Key Features:

• Higher pulse count (120 pulses per catheter)

• Smaller crossing profile for easier lesion access

• Comprehensive size range for various vessel diameters

Regulatory Approvals & Market Expansion

• In 2025, SONICO-CX received regulatory approval from DIGEMID in Peru, marking a major milestone in Latin America.

• Previously, the device was approved by ARCSA in Ecuador, with ongoing regulatory processes in other Latin American and Southeast Asian markets.

• The company is actively working towards approvals in major healthcare markets, including the European Union and the United States.

Research & Clinical Applications

Spectrumedics Medical collaborates with leading cardiovascular specialists and research institutions to advance the clinical understanding of IVL technology. The company participates in clinical trials, academic publications, and industry conferences such as TCT and EuroPCR to promote evidence-based adoption of IVL.