Innovation is alive and well at Abbott Laboratories, where the global health firm earned a 2011 Wall Street Journal Technology Innovation Award for its http://www.abbott.com/news-media/press-releases/2011-oct17.htm™ Bioresorbable Vascular Scaffold.
The Abbott Park, IL-based company noted that the award marked the fourth recognition in the Technology Innovation Awards for Abbott in five years. The company's press release explained, "ABSORB is an implantable device that restores blood flow by opening a blocked artery and providing support to the vessel until the device dissolves. Once in place, ABSORB dissolves in approximately two years, leaving patients with a treated vessel free of a permanent metallic implant.
"The first drug eluting device of its kind for coronary artery disease, ABSORB is made of polylactide, a proven biocompatible material that is commonly used in medical implants such as dissolvable sutures. Because a permanent metallic implant is not left behind, naturally occurring vessel functions may be restored, which is one of the features that make this device a significant innovation for patients in the evaluation and treatment of coronary artery disease."
"ABSORB represents the best in scientific innovation, as it has the potential to change the way physicians practice medicine and improve outcomes for their patients," said Robert B. Hance, senior vice president, vascular, Abbott. "We are pleased that this innovation, which has been developed in the U.S. over nearly a decade, has the prospect of advancing patient care around the globe. Abbott is honored to receive this prestigious award."
In January, Abbott announced that ABSORB received CE Mark in Europe for the treatment of coronary artery disease. In the United States, ABSORB currently is under development and is not available for sale. ABSORB is being evaluated in more than 40 clinical centers in 20 countries around the world.
Abbott spokesperson Jonathon Hamilton told Healthcare Packaging that ABSORB is manufactured at the company's California facilities in a clean room environment. He said that three sizes have been granted with the CE Mark, (2.5 x 18mm, 3.0 x 18, and 3.0 x 28mm).
Asked if ABSORB would be considered a combination product, Hamilton said, "ABSORB is its own product class--a drug and bioresorbable device combination product. The device has enough unique attributes that it merits its own class."
What type of material is the device placed into? "It is placed into the same kind of packaging used with traditional drug-eluting stent--a coil, foil pouch, and a box," he said, noting that the company did not disclose packaging supplier details. The product is shipped and stored similarly to traditional stents, he said.
As far as competitive devices, Hamilton told Healthcare Packaging, "The design and performance of ABSORB puts Abbott years ahead of any company attempting to develop a BVS technology and is an example of how the company is revolutionizing the way patients with coronary artery disease are treated. Given the numerous technical challenges involved in creating a stent from a dissolvable polymer, Abbott is the only company of the major stent manufacturers to pursue development of a fully bioresorbable drug-eluting device to treat coronary artery disease."
Looking ahead, Hamilton said, "We are working with the FDA to define the required data and timing of our U.S. clinical trial. Assuming all proceeds as anticipated, we plan to enroll the first patient in the global trial in the first half of 2012. We anticipate submitting ABSORB for U.S. approval in 2015; we are not speculating on the timing for commercial availability. We are also working with regulatory authorities in Japan and other markets to bring the ABSORB device to more patients."
The Abbott Park, IL-based company noted that the award marked the fourth recognition in the Technology Innovation Awards for Abbott in five years. The company's press release explained, "ABSORB is an implantable device that restores blood flow by opening a blocked artery and providing support to the vessel until the device dissolves. Once in place, ABSORB dissolves in approximately two years, leaving patients with a treated vessel free of a permanent metallic implant.
"The first drug eluting device of its kind for coronary artery disease, ABSORB is made of polylactide, a proven biocompatible material that is commonly used in medical implants such as dissolvable sutures. Because a permanent metallic implant is not left behind, naturally occurring vessel functions may be restored, which is one of the features that make this device a significant innovation for patients in the evaluation and treatment of coronary artery disease."
"ABSORB represents the best in scientific innovation, as it has the potential to change the way physicians practice medicine and improve outcomes for their patients," said Robert B. Hance, senior vice president, vascular, Abbott. "We are pleased that this innovation, which has been developed in the U.S. over nearly a decade, has the prospect of advancing patient care around the globe. Abbott is honored to receive this prestigious award."
In January, Abbott announced that ABSORB received CE Mark in Europe for the treatment of coronary artery disease. In the United States, ABSORB currently is under development and is not available for sale. ABSORB is being evaluated in more than 40 clinical centers in 20 countries around the world.
Abbott spokesperson Jonathon Hamilton told Healthcare Packaging that ABSORB is manufactured at the company's California facilities in a clean room environment. He said that three sizes have been granted with the CE Mark, (2.5 x 18mm, 3.0 x 18, and 3.0 x 28mm).
Asked if ABSORB would be considered a combination product, Hamilton said, "ABSORB is its own product class--a drug and bioresorbable device combination product. The device has enough unique attributes that it merits its own class."
What type of material is the device placed into? "It is placed into the same kind of packaging used with traditional drug-eluting stent--a coil, foil pouch, and a box," he said, noting that the company did not disclose packaging supplier details. The product is shipped and stored similarly to traditional stents, he said.
As far as competitive devices, Hamilton told Healthcare Packaging, "The design and performance of ABSORB puts Abbott years ahead of any company attempting to develop a BVS technology and is an example of how the company is revolutionizing the way patients with coronary artery disease are treated. Given the numerous technical challenges involved in creating a stent from a dissolvable polymer, Abbott is the only company of the major stent manufacturers to pursue development of a fully bioresorbable drug-eluting device to treat coronary artery disease."
Looking ahead, Hamilton said, "We are working with the FDA to define the required data and timing of our U.S. clinical trial. Assuming all proceeds as anticipated, we plan to enroll the first patient in the global trial in the first half of 2012. We anticipate submitting ABSORB for U.S. approval in 2015; we are not speculating on the timing for commercial availability. We are also working with regulatory authorities in Japan and other markets to bring the ABSORB device to more patients."
