Tecnología Médica

Genie

The GENIE™ is a drug delivery catheter designed to deliver various liquid therapeutic agents, such as paclitaxel, into specific segments of the arteries. 

With the GENIE™, cardiologists can expose coronary arteries to low dose of paclitaxel to prevent stenosis.

This new approach has been described as a potential alternative to Drug Eluting Stent (DES) as a prevetion of restenosis after implantation of a bare metal stent (Herdeg et al. 2009).

 

Key Features

·         No footprint: Delivers drug without any polymer or additional coating. Low amount of paclitaxel left on site.

·         Deep and homogeneous: Drug is homogeneously applied on the whole vessel surface in opposition to strut coating. Distal and proximal stent segments are optimally covered by pharmacotherapy. 

·         Atraumatic: Operates at low pressure

 

Indications

·         Intra-Stent Restenosis: Apply antirestenotic drug homogeneously along the stent and its edges, without additional metallic material.

·         Patients unfit for long-term anti-platelet therapy: 130 to 170 μg of Paclitaxel is sufficient to obtain desired results. Only about 2.9 to 3.7 μg of paclitaxel remain in the vessel wall. This reduces the need for long-term anti-platelet therapy, particularly appropriate for elderly people.

·         Mutli-segment lesions: The same device can be used to treat several lesions in the same artery, during the same procedure. Ideal for the treatment of multi-segment lesions.
 

Clinical Studies

·         Randomized trial in 204 patients concludes that the treatment of de novo lesions with the GENIE after bare metal stenting (BMS) is safe; the results in terms of clinical events and restenosis are better than BMS alone and equivalent to a drug-eluting stent (TAXUS). 

·         Animal study on 30 pigs shows that local delivery of Paclitaxel via the GENIE is safe and effective to significantly reduce the proliferative response post-stent implantation or balloon dilatation.

·         Only few minutes exposure to Paclitaxel is sufficient to have a long-lasting antiproliferative effect on human arterial smooth muscle cell.

·         Other Publications

·         Local Paclitaxel Delivery for the Prevention of Restenosis: biological effects and efficacy in vivo, Herdeg et all., JACC 2000” 

·         “Addition of Paclitaxel to Contrast Media Prevents Restenosis after Coronary Stent Implantation, Scheller et all., JACC 2003” 

·         “Successful local antiproliferative paclitaxel delivery in a repeatedly restenosed lesion of the right coronary artery after drug eluting-stent implantation, Herdeg et all., Clin Res. Cardiol 2008”.