Abbott has signed an agreement with intravascular medical devices maker Surmodics for an investigational next-generation drug-coated balloon SurVeil designed to treat the superficial femoral artery.
The SurVeil drug-coated balloon is intended to broaden Abbott’s range of vascular devices such as stents and vessel-closure products meant for helping patients with peripheral artery disease (PAD).
Under the terms of the agreement, Surmodics will supply SurVeil to Abbott and the firms will jointly work on the drug-coated balloon’s development, clinical trials, and regulatory activities in the US and Europe.
Currently being studied in a US-based trial called TRANSCEND, SurVeil includes a drug-excipient formulation to ensure durable balloon coating and is prepared using a unique process to enhance the uniformity of the coating.
According to data from pre-clinical models, SurVeil demonstrated higher target tissue drug concentration, durable drug effect, and lower downstream drug particle incidence, when compared to the control drug-coated balloon.
Abbott vascular business senior vice-president Chuck Brynelsen said: “Abbott is committed to providing leading treatments for people with PAD, and the SurVeil drug-coated balloon is a next-generation device that utilises best-in-class technology.
“This agreement enhances our fast-growing endovascular portfolio, and we look forward to offering this solution to physicians to give them more and better options to help their patients live their fullest lives.”
As per the agreement, Abbott will make an upfront payment of $25m, along with another $67m in potential milestone payments based on product development.
After obtaining regulatory approval, Surmodics will manufacture and supply clinical as well as commercial quantities of the device, and will realise revenue from initial sales and share of profits from third-party to Abbott.
The terms of the deal also provide Abbott with an option to negotiate for Surmodics’ pre-clinical below-the-knee and arteriovenous (AV) fistula drug-coated balloon products.