Chinese Herbal Medicine on Cardiovascular Diseases and the Mechanisms of Action



kr coronary stent :: Article Creator

CORONARY STENTS

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FDA Clears Gentuity Imaging System For Coronary Interventions

Gentuity Nipro HF-OCT imaging console for imaging catheterThe Gentuity HF-OCT imaging console. [Image from Nipro]Gentuity announced today that it received FDA 510(k) clearance for its HF-OCT imaging system with the Vis-Rx micro-imaging catheter.

Sudbury, Massachusetts-based Gentuity received approval for the technology for use both before and after percutaneous coronary intervention (PCI). The company said this makes it the only intravascular imaging platform specifically indicated for the assessment of the coronary vessel pre- and post-intervention.

According to a news release, recent studies showed that pre-PCI imaging with OCT led to changes in procedural strategy of 80% of lesions. That includes lesion assessment (45%), vessel preparation strategy (27%), stent diameter (37%) and stent length (36%).

Building on this, Gentuity developed and commercialized its Vis-Rx micro-imaging catheter. The company says that, at 1.8 F, it represents the world's smallest imaging platform. Its low crossing profile also enables essential pre-PCI imaging, reducing the need for pre-dilation. The system also streamlines the procedural workflow and enhances intervention accuracy by allowing clinicians to assess coronary arteries in their native state.

"We are excited to receive this FDA clearance, which marks a major milestone for the Gentuity HF-OCT imaging system," said Desmond Adler, president of Gentuity. "The ability to image pre-PCI where it is most needed—without pre-dilation—offers clinicians unparalleled opportunities to optimize treatment plans and obtain previously unavailable insights throughout the entire procedure.

"Combined with our AI-guided analysis tools, best-in-class scan range for left main and bifurcation assessment, and seamless device setup, the Gentuity HF-OCT Imaging System is truly an indispensable tool for advancing patient care."

Nipro serves as the global distribution partner for Gentuity.


Carotid Artery Stent Procedure

Content

You may need to stay in the hospital for one or two days. Before you leave the hospital, your doctor will give you guidelines for activities, diet, and medications. We will also give you your Stent Implant Card which has important information regarding your Carotid Stent.

After discharge, call us immediately if you have any new symptoms or worsening of the symptoms you had before the stent placement, including: 

  • Severe headache
  • Slurred speech
  • Problems at your puncture site such as increasing swelling, pain or bleeding
  • Weakness or numbness affecting one side of your body (for instance, your right arm, leg, or face becomes weaker than your left)
  • Blurry vision or sudden loss of vision, one or both eyes
  • Because medications will be an important part of your treatment, your doctor will prescribe many to take at home. It is important to follow your medication regimen exactly. These medications will help prevent blood clots from forming in the newly opened carotid artery. Notify us if your medications cause unpleasant reactions, but do not stop taking them unless instructed to do so. Your doctor may be able to prescribe new medications that better suit you. It is important to keep all scheduled follow-up appointments.

    There is always a chance of complications from any procedure. These include: 

  • Allergic reactions
  • Bleeding
  • Heart attack
  • Stroke or TIAs
  • Death
  • Damage to your blood vessels
  • Emboli
  • Blood clots or re-narrowing blocking blood flow through the stent
  • Infection
  • Bruising of your groin area at the catheter insertion site
  • Note: Sometimes, we prescribe combinations of antiplatelets and anticoagulants to decrease the risk of forming a blood clot in your artery. If your pharmacist tells you that the medications cannot be taken as your doctor ordered, please contact him at the office.






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