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FIREHAWK

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FIREHAWKTM Rapamycin Target Eluting Coronary Stent System

FIREHAWKTM Rapamycin Target Eluting Coronary Stent System product is consisted of a balloon-expandable coronary stent, drug coating which filled in grooves that located on outside surface of stent, and delivery system.

The coronary stent is made of cobalt-based alloy tubes by laser cutting. The coating on the stent is consisted of antiproliferative drug Rapamycin and bioabsorbable polylactic acid (PLA) which filled inside the grooves that located on the outside surface of the stent.


Indications:

FIREHAWKTM Stent System is indicated for the following indications :

  • Ischemic heart disease patient with coronary lesion length less than or equal to 38mm , and with vessel diameter of 2.25-4.0 mm
  • Protected left main coronary artery diseases
  • PTCA treatment or surgery with unsatisfied result or with postoperative occlusion and restenosis

   
Contraindications:

FIREHAWKTM Stent System is contraindicated for the following types of patients :

  • Patients allergy to or resistant to rapamycin and its derivatives, cobalt based alloys, or polylactic acid
  • Patients ca not receive anticoagulant or antiplatelet therapy
  • Patients with severe calcified lesions and extremely distorted lesions that can not be successfully pre-dilated, thus can not accurately conduct stent delivery and deployment.
  • Lesion diameter <2.25 mm or > 4.0 mm
  • Patients with unprotected left main disease

Adverse events  / Complications :

Adverse events related to stent implanted in coronary artery are not limited to the following adverse events :

  • Target lesion revascularization
  • Non target lesion and target vessel revascularization
  • MI
  • In-stent restenosis
  • Allergic reactions
  • Aneurysm
  • Arrhythmia
  • Cardiac tamponade
  • Death
  • Vascular dissection
  • Reactions of drugs to anti-platelet drugs /anticoagulant drugs /contrast agent response
  • Distal embolization of vessel
  • In-stent thrombosis
  • Emergency CABG
  • Stent not delivered to the lesion
  • Fever
  • Fistula
  • Bleeding
  • Low blood pressure / hypertension
  • Lesion infection and pain
  • Pseudoaneurysm caused by femoral artery puncture
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