US-based AtriCure has received approval from China’s National Medical Products Administration (NMPA) to market its AtriClip devices in the country.
The approval allows AtriCure to market and distribute multiple models of its AtriClip Left Atrial Appendage (LAA) Exclusion System in China.
AtriClip is engineered to exclude and electrically isolate the left atrial appendage during cardiac surgery. The left atrial appendage is a primary site for blood clot formation in individuals with atrial fibrillation.
The latest regulatory approval will allow AtriCure to deliver crucial treatments for patients affected by Afib and the health risks associated with it.
AtriClip device’s approval in China is based on clinical data that showcased its safety and effectiveness.
AtriCure said that the devices are known for their design, which ensures complete exclusion and subsequent elimination of the LAA through ischemic necrosis.
AtriClip devices have been used on over 550,000 patients globally, claimed the company.
Furthermore, AtriCure intends to collaborate with medical institutions and practitioners in China to offer thorough training and support to uphold standards of patient care.
Concurrently, the company will engage with Chinese regulatory bodies to expedite the introduction of further products in the years ahead.
AtriCure president and CEO Michael Carrel said: “We are committed to expanding access to treatment and enhancing patient outcomes globally and are thrilled to receive approval to treat patients with our AtriClip devices in China.
“While patients have been benefitting from our surgical ablation devices in China for many years, this is a major step forward in our global expansion strategy.
“China represents a significant market opportunity, and we look forward to working with our partners and healthcare providers across the country to deliver our innovative solutions.”
AtriCure develops surgical solutions for atrial fibrillation, LAA management, and post-operative pain management.
Its Isolator Synergy Ablation System is said to be the first US Food and Drug Administration (FDA)-approved medical device for treating persistent atrial fibrillation.
Other products include the AtriClip Left Atrial Appendage Exclusion System, Hybrid AF Therapy, and AtriCure’s cryoICE cryoSPHERE probes.
