Dave Fornell, DAIC Editor

Dave Fornell, editor of DAIC Magazine

Blog | Dave Fornell, DAIC Editor | Stents Bioresorbable| August 16, 2016

Tempering the Bioresorbable Stent Euphoria Following FDA Clearance of the Absorb

Absorb, bioresorbable stent, BVS, on OCT

An optical coherence tomography (OCT) image of an Absorb bioresorbable stent. The stent struts are clear, allowing light to pass through, and in some cases magnifying the light that passes through under each strut. Image courtesy of St. Jude Medical.

There was an explosion of interest in bioresorbable stents immediately following the July 5, 2016 announcement that the U.S. Food and Drug Administration (FDA) had cleared the first fully bioresorbable coronary stent for the U.S. market. The Abbott Absorb is a first-of-its-kind medical device commercially available to treat U.S. patients with coronary artery disease. It completely dissolves in about three years, leaving nothing behind except for the tiny radiopaque markers that denote the ends of the stent on angiography. I saw first-hand the euphoria that this news brought in the medical community, many viewing the news similar to the first moon landing in terms of technological achievement. 

The DAIC article announcing the FDA approval had more website page views in the course of a couple days than the next 10 most popular 2016 DAIC articles combined since January. On social media we saw this story shared an astronomical number of times. We also saw a massive traffic boost for all our archive articles and videos about bioresorbable stent technology. Any articles posted since the FDA approval that use the word “bioresorbable” also see immediate spikes in traffic.

Monitoring social media comments on the story showed an incredible interest in the topic by both U.S.-based and international cardiologists, cath lab nurses and techs. Many boasted about their lab's involvement in the ABSORB trials, or how they were going to be the first in their region to implant an Absorb stent post-FDA approval. Others seemed to be clamoring for more information about the new technology. 

Despite the Absorb having been available for a few years overseas, international interest in the FDA clearance boomed as well, based on the locations of people accessing our content. I believe this is because an FDA approval of a new technology is only achieved after proving safety AND efficacy. This is unlike European CE mark approval, which is aimed at proving a device is safe to implant in a patient, not necessarily that it works well. 

However, in the modern era of basing patient care decisions on hard clinical data, this enthusiasm should be tempered. The Absorb bioresorbable stent technology is a first step toward a new shift in care, not an end in itself. It is comparable to the first introduction of balloon angioplasty without stents, or the first drug-eluting stent that had its own faults and limitations. One of the big news items about the technology from TCT 2015 and ACC 2016 were data presentations on the limitations of the Absorb. These include poorer outcomes compared to metallic stents in vessels smaller than 2.5 mm; its very thick struts making it less agile or undeliverable in tortuous vessels; the difficulty in visualizing the stent on angiography; and the need to be much more precise in lumen measurements and stent sizing because the stent will fracture if overinflated. 

Imaging of bioresorbable stents during delivery and proper vessel sizing will be the biggest challenges for novice users, so we are highlighting the article “Role of Imaging in Bioresorbable Stent Procedures” in the Sept-Oct issue of DAIC

Additional information on the new Absorb stent users should be aware of can be found in my video interview with Dr. Gregg Stone at ACC.16, where he presented data on poor outcomes for bioresorbable stents in small coronary arteries. Watch the video at http://bit.ly/1qpTcgn

The article “Questions Remain on Future of Bioresorbable Stents” also offers more information on the limits of the Absorb’s current technology. 

(UPDATE: read the Sept. 8, 2017 article "Abbott Will End Sales of Absorb Bioresorbable Stent")
 

Related Content

Gallery | Cath Lab | October 31, 2019
This is a photo essay of the interventional cardiology and structural heart technologies on the expo floor and discus
The Alphenix Aero Package from Canon Medical Systems USA, Inc. enables OBLs and ASCs to attain premium technology at a flexible price point by tailoring Canon Medical’s Alphenix systems to fit their facilities’ needs.

The Alphenix Aero Package from Canon Medical Systems USA, Inc. enables OBLs and ASCs to attain premium technology at a flexible price point by tailoring Canon Medical’s Alphenix systems to fit their facilities’ needs.

Technology | Cath Lab | October 28, 2019
Office based labs (OBLs) and ambulatory surgery centers (ASCs) require a fresh perspective from imaging vendors.
Marco Costa, M.D., Ph.D., MBA, president, UH Harrington Heart and Vascular Institute, performing a cath lab procedure.

Marco Costa, M.D., Ph.D., MBA, president, UH Harrington Heart and Vascular Institute, performing a cath lab procedure.

News | Cath Lab | October 28, 2019
October 28, 2019 — Leaders within University Hospitals and the Harrington Heart and Vascular Institute had a vision t
OmniVision Announces Guinness World Record for Smallest Image Sensor

OmniVision's OVM6948 CameraCubeChip, a fully packaged, wafer-level camera module measuring 0.65mm x 0.65mm x 1.158mm, built on OmniVision's OV6948, winner of the Guinness World Record for “The Smallest Image Sensor Commercially Available.”

News | Cath Lab | October 22, 2019
October 22, 2019 — OmniVision Technologies Inc.
People watch the presentation of the five-year EXCEL Trial data by Gregg Stone, M.D., live in the Abbott booth at TCT 2019. Abbott makes the Xience stent used in the trial, which compared equally with long term surgical outcomes. #TCT2019

People watch the live presentation of the five-year EXCEL Trial data by Gregg Stone, M.D., in the Abbott booth at TCT 2019. Abbott makes the Xience stent used in the trial, which compared equally with long-term CABG surgical outcomes. 

Feature | Cath Lab | October 03, 2019
October 3, 2019 – Five-year data from the EXCEL Trial showed patients with left main coronary disease treated with pe
Two Stents Implanted in Democratic Presidential Candidate Bernie Sanders, suffers chest pain
News | Cath Lab | October 02, 2019 | Dave Fornell, Editor
October 2, 2019 — Democratic presidential candidate Sen.
Bypass Surgery and Coronary Stenting Yield Comparable 10-Year Survival
News | Cath Lab | September 25, 2019
Ten-year survival rates are similar for bypass surgery and coronary stenting with drug-eluting stents in randomized...
Complete Revascularization Superior to Culprit Lesion-only Intervention
News | Cath Lab | September 10, 2019
An international randomized trial has shown that complete revascularization reduces major cardiovascular events...
The cath lab staff UH Portage Medical Center.

The cath lab staff UH Portage Medical Center.

Feature | Cath Lab | September 09, 2019 | Anjan Gupta, M.D., FACC, FSCAI
Primary percutaneous coronary intervention (PCI) is the preferred treatment for acute...
Overlay Init