Delivery of antirestenotic drugs with the drug-coated balloon AGENT: interview with Dr. Ian Meredith, Global CMO, Boston Scientific

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Boston Scientific recently announced a clinical trial of its AGENT drug-coated balloon. The device is coated with paclitaxel, an anti-restenotic drug, and aims to administer the drug to the wall of the affected vessel during a percutaneous procedure. In-stent coronary restenosis (SRI) is caused by occlusive scar tissue that develops in the stent portion of a vessel.

Currently, SRI is treated by the addition of additional stents and sometimes radiotherapy is also used. Both of these approaches present safety risks for patients. Balloon angioplasty represents an alternative approach, but it is not always successful, with mixed or modest efficacy. The latter technology aims to improve the efficacy of balloon angioplasty in SRI by combining it with localized drug administration to the vessel wall.

The balloon opens the occluded vessel and then delivers paclitaxel to the vessel wall to help reduce stenosis. Boston Scientific recently began the AGENT IDE clinical trial to verify the safety and efficacy of the device. Medgadget He had the opportunity to speak with Ian Meredith, MD, global medical chief executive at Boston Scientific, about the technology.

Conn Hastings, Medgadget: Tell us about in-stent coronary restenosis and how the disease is currently treated.

Dr. Ian Meredith, Boston Scientific: In-stent restenosis (SRI) refers to the growth of scar tissue over time inside the stent section of a coronary artery. This scar tissue eventually obstructs blood flow to the artery causing symptoms similar to the constipation that was initially treated with a stent. Although the coronary stent continues to show a substantial improvement in the quality of life of patients with coronary artery disease, RIS can occur occasionally.

SRI occurs after percutaneous coronary interventions (PCI) in approximately 10% of cases. Current treatment practices include simple balloon dilation known as “old” balloon angioplasty (POBA), insertion and stratification of additional stents, or radiation. Both a second layer of stents and radiation introduce possible safety risks for patients.

Medgadget: Please give us an overview of the AGENT medicated coated balloon and how it works.

Dr. Meredith: AGENT DCB is a percutaneous transluminal coronary angioplasty (PTCA) balloon catheter coated with an antirestenotic drug and delivered to the wall of the affected vessel using its own coating technology. The FDA has granted the designation of innovation device earlier this year, which is designed to open small vessels and help treat and reduce the recurrence of SRIs.

Medgadget: How does the balloon transfer the drug to the wall of the ship and allow for sustained efficacy? Is the drug encapsulated in a delivery material, such as a hydrogel or a nanoparticle?

Dr. Meredith: The excipient (carrier) of the coating has unique properties that allow it to maintain its integrity while effectively transferring a low dose of therapeutic drug to the tissue. This translates into low systemic exposure to drugs for patients.

Medgadget: How does the Drug Coated Agent Balloon improve on current treatment options?

Dr. Meredith: Current ISR treatment strategies include POBA of scar tissue, which is modest and inconsistently effective, or repeated insertion of additional stretches or radiation. The addition of additional stents or the use of radiation therapy may carry potential safety risks. AGENT DCB was designed in response to the response of physicians who needed a metal-free, radiation-free treatment alternative for their patients with coronary SRI that would result in a prediction and lasting effect. AGENT supplies the antirrestotic drug paclitaxel to the vessel wall without the need for another permanent stent implant.

Medgadget: Give us an overview of the upcoming AGE IDE test.

Dr. Meredith: The IDE AGENT study is the first clinical trial of a drug-coated coronary balloon (DCB) in the U.S. and will evaluate the safety and efficacy of the DCB AGENT for the treatment of coronary SRI. This prospective, randomized study will compare the SRI treatment with the DCB AGENT with the uncoated balloon treatment (POBA). The study will assess the 12-month target injury failure rate, defined as myocardial infarction related to the target vessel, the need for a revascularization procedure, or cardiac mortality. At least 480 patients will be enrolled in the study at 40 locations in the US.

* Agent DCB is a research device in the United States and is not available for sale.

More information about the AGENT balloon:

Link: PTCA Coated-Paclitaxel Agent Balloon Catheter Device Information Page …

Flashback: Boston Scientific agent with drug-coated balloon gets green light in Europe





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