Based on Indian data, absorbable stent gets US FDA tag

Experts said Indian data was crucial in clinching the US FDA stamp for the stent.
Based on Indian data, absorbable stent gets US FDA tagMUMBAI: There is a strong 'India' connect to the absorbable stent that got the United States Food and Drug Administration (FDA) approval on Tuesday.

The absorbable stent, which disappears within three years of being placed in a heart patient’s blood vessel, has been in use in India for almost four years now. While over 10,000 such stents have already been used across Indian metros, there also are hundreds of patients in whom the absorbable stent has already "disappeared" after being placed in 2012.

Experts said Indian data was crucial in clinching the US FDA stamp for the stent. In fact, Delhi-based cardiologist Dr Ashok Seth was called by the US FDA in March to present his experience with using this stent. Moreover, the team developing the stent for Abbott Vascular in California had an Indian scientist, Santosh Prabhu, who is a former student of IIT Bombay.

The stent has been hailed as an innovations in heart care but comes with a premium tag, costing Rs 1.9 lakh each (the usual drug-coated stents cost between Rs 75,000 and Rs 1.4 lakh for the latest version).

A press release sent out by the US FDA on Tuesday said, "The absorbable stent, called the Absorb GT1 Bioresorbable Vascular Scaffold System (BVS), releases a drug (called everolimus) to limit the growth of scar tissue; it is gradually absorbed by the body in approximately three years.’’

The press release further said that the Absorb GT1 BVS is manufactured from a biodegradable polymer called poly (L-lactide), which is similar to materials used in other types of absorbable medical devices, such as sutures. "The device’s absorption by the body gradually eliminates the presence of foreign material in the artery once the stent is no longer needed. After absorption, there are only four very small platinum markers embedded in the walls of the artery, which help cardiologists identify where the Absorb GT1 BVS was originally placed," it added.

The absorbable stent hasn’t been without its share of controversies, with doctors complaining of difficulty in deploying the stent as well as the need to choose patients very carefully. The US FDA release addressed all these issues: "In approving the Absorb GT1 BVS, the FDA evaluated data from a randomized trial of 2,008 patients, which compared the rate of major adverse cardiac events between the Absorb GT1 BVS and a drug-eluting metallic stent.’’

The release also said that, after one year, the Absorb GT1 BVS group showed a major cardiac adverse event rate of 7.8%, which was clinically comparable to the rate of 6.1% observed in the control group. In addition, after one year, the rate of blood clots forming within the devices was 1.54 % for the Absorb GT1 BVS and 0.74 % rate for the control.

As a note of caution, the release said, "The Absorb GT1 BVS is contraindicated for patients who have a known hypersensitivity or allergy to everolimus or the materials used in the device, such as poly (L-lactide), poly (D,L-lactide), or platinum.’’ It is also contraindicated for those who are not candidates for angioplasty, have sensitivity to contrast, or who cannot take long-term aspirin therapy along with other blood-thinning medications (antiplatelet agents).


appiIMAIDAHealthcare Federation of IndiaAIMENeoCon2015