The Bluhm Cardiovascular Institute of Northwestern Memorial HealthCare in Chicago, US, has enrolled the first patient in ABSORB III, a clinical trial to understand the safety and effectiveness of Abbott's absorb bioresorbable vascular scaffold (BVS) in comparison to a traditional drug eluting a metallic stent.
The Bluhm Cardiovascular Institute has become the first centre in Chicago to enroll subjects for the ABSORB III trial.
Similar to a small mesh tube, the investigational device combines the characteristics of a dissolvable material with the established multilink stent design, thereby making the scaffold flexible and conformable to the vessel.
Designed to perform like a metallic stent, the Absorb BVS opens a blocked coronary artery and restores blood flow to the heart; however, this gets dissolved over time unlike a traditional stent, which remains in the body permanently.
The Absorb BVS, made of polylactide, which is a dissolvable material used in medical implants, dissolves completely into the blood vessel leaving only two pairs of tiny metallic markers thereby assisting the physician in locating the device with ease.
For more than 30 years, doctors have been treating several coronary artery disease cases (CAD) with balloon angioplasty and the placement of stents and for more severe cases, coronary artery bypass surgeries have also been done.
They have been using a stent, which is a small, mesh coil made up of metal or coated with medications, in order to keep the artery open.
These drug eluting stents keep the artery open to reduce the risk of future blockages.
Northwestern Memorial director of interventional cardiology and Northwestern University Feinberg School of Medicine associate professor Ricciardi noted that since the 1980s, these technologies have allowed many patients to avoid open heart surgery.
Ricciardi said: "While we've had great success with the current technology, once a stent is placed, it remains in the body forever.However, the stent support is really only needed for several months."
Data from the ABSORB III trial will help support the US regulatory filings for Absorb.
Approximately 2,250 subjects will be enrolled for the clinical trial at various centres, and a majority of the participants will be from the US.
While Absorb is authorised for sale in CE Mark countries, it is also available in the Middle East, parts of Latin America, and parts of Asia Pacific, including India, Hong Kong, Malaysia and New Zealand.