Castor branched aortic stent graft gains CFDA approval

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The Castor branched aortic stent graft system, developed by MicroPort Endovascular, has obtained the regulatory approval from China Food and Drug Administration (CFDA), formally entering the Chinese market.

Thoracic endovascular aortic repair (TEVAR) for the treatment of aortic dissection has experienced rapid development and been widely accepted in the past 20 years. However, MicroPort Endovascular says “there still does not exist a stent graft especially designed for aortic arch, which can dispose with challenges inherent with the anatomy of the aortic arch.” Such challenges include:

  • How to get to and precisely locate in the tortuous aortic arch
  • How to deal with anatomy diversity of the aortic arch
  • How to reconstruct the supra-arch vessels.

President Zhenghua Miao from MicroPort Endovascular said, “From 2006 on, MicroPort Endovascular started on the development of Castor, which is globally the first branched stent graft especially designed for the aortic arch, with the single branch extending into the left subclavian artery.”

Castor is for the treatment of thoracic dissection encroaching into the left subclavian artery or the original tear located within 20mm distal to the left subclavian artery and 15mm distal to the left carotid artery. Thus treatment in zone 2 can be completed without any adjunctive surgical procedure.

Castor adopts the “unibody design”, which sews the main body and branch stent together to make it possible to deploy and release at the same time, effectively avoiding type III endoleak and long-term migration.

Castor employs standardised design with high compatibility to various arch anatomies. The tapered size is exclusive to aortic dissection. The delivery system employs a dual-sheath design and the stent graft is delivered to the aortic arch under the protection of a soft sheath. The orientation and position of the branched stent is assured by patented wire-controlled, pull-in design. Accurate and fast deployment is achieved by a wire-controlled mechanism

Zaiping Jing from Shanghai Changhai Hospital said, “Castor is the first stent graft that can simultaneously repair the aortic arch, left subclavian artery and the descending aorta, whose clinical safety and performance has been fully supported by a 73-case premarket clinical study with 97.6% technical success, 5.5% 12-month all-cause mortality, 4.1% 12-month endoleak and 2.7% 12-month stroke, 69% of which are acute aortic dissection. Although there have been several ways to treat thoracic dissection involving the left subclavian artery, branched stent grafts offer the most promising technique in the near future. Applying Castor in combination with chimney or fenestration technique can deal with dissections encroaching left carotid artery or innominate artery, achieving a complete endovascular repair of the aortic arch.”

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