Contract manufacturing Drug-coated balloons: Surmodics SurVeil versus Medtronic Admiral
In January 2021, Surmodics reported insights gleaned from 12 months of data collection in its TRANSCEND clinical trial, which is being run to compare the effi cacy between Medtronic’s Admiral drug-coated balloon (DCB) and its own SurVeil DCB. The performance of both devices was measured in a global, multicentre, randomised, controlled clinical trial, in patients with symptomatic femoropopliteal artery disease. The primary results showed the SurVeil DCB was found to be non-inferior to the
IN.PACT Admiral DCB in both the primary safety and primary effi cacy end points. The SurVeil DCB cohort of 222 patients exhibited a strong safety profi le, with 91.7% of subjects demonstrating freedom from device or procedure-related death within 30 days, and freedom from above-ankle amputation or CD-TVR within 12 months. This was compared with 89.6% of the 224 patients treated with the
IN.PACT Admiral DCB. Both the SurVeil and
IN.PACT Admiral DCBs use coatings with the anti- proliferative drug paclitaxel. However, the
IN.PACT Admiral DCB has a 75% higher drug load of paclitaxel (3.5µg/mm2
) than the SurVeil DCB, which has
a 2.0µg/mm² drug load. In February 2018, Surmodics entered into an agreement with medical device company Abbott, which provided it with exclusive worldwide commercialisation rights for the SurVeil DCB. Upon the regulatory approval of the device, Surmodics will be responsible for manufacturing clinical and commercial quantities of the product, and will realise revenue from product sales to Abbott as well as a share of profi ts resulting from sales to third parties. The SurVeil DCB received CE Mark
certifi cation in the EU in June 2020. Source: Surmodics
resources, which will ultimately save them time and money.
“There’s risk and there’s reward to what Minnetronix has done.”
Minnetronix’s new focus on manufacturing its own products doesn’t mean it’s totally independent. Rather, the company worked closely with Grande and his colleagues at the University of Minnesota to develop the Neurapheresis – an experience the academic says he has greatly appreciated. It helps that they’re practically neighbours – Grande’s office is barely a mile from Minnetronix – which he says
has dramatically boosted the creative process. “As a physician, I’ve always felt valued by Minnetronix, which has been a lot of fun,” he says. “I’ve just enjoyed working with them.” That’s been true, Grande adds, right from the start, from early product development and testing, through clinical trials and regulatory approval.
Balancing act
That last point – regulatory approval – is worth considering in more detail. Put it like this: you can have the most spectacular idea in medical history, but it won’t mean much if the FDA refuses to authorise it. Happily, it seems that here, too, Minnetronix has built a system that works. Because the company both designs and manufactures its own kit, Grande suggests that it has an easier time getting machines approved. As he puts it: “Keeping it in house streamlines things and makes it more efficient.” It’s a point bolstered by the company’s recent regulatory successes. Approved in December 2020, the MindsEye Port is a tool that helps surgeons access otherwise inaccessible corners of the brain. The Neurapheresis, for its part, has successfully jumped preliminary FDA hurdles and is currently undergoing further tests. What does this mean over the years ahead?
The MindsEye Port, a tool approved in December 2020, which helps surgeons reach otherwise inaccesible corners of the brain.
50
It’s tempting to take Minnetronix’s triumphs as evidence that the future belongs to OEMs – or at least contract manufacturers that take up their mantle. Yet, as Minnetronix’s own model implies, this is by no means a zero-sum game. After all, the company isn’t abandoning its CDMO heritage, and to this day it continues to build third-party components, even as it sharpens the Neurapheresis and its other creations. This makes sense, Grande says, as a way of balancing risk and reward. “There’s risk and there’s reward to what Minnetronix has done,” he says. “For any company’s individual board, [the question is] what is the risk that it’s willing to take on?” More broadly, the popularity of contract manufacturing seems to be going nowhere but up. Beyond that landmark $76bn figure, indeed, regions like Asia and the Pacific are proving particularly dynamic. In China alone, the local CDMO medical device industry is expected to reach $22.8bn by 2027, while similar growth can be seen in India and other emerging economies. Together with ever more robust intellectual property laws and better supply chains, there’s no reason to doubt that these developing countries can’t continue to become CDMO champions. To put it another way, contract manufacturers seem unlikely to disappear – even once sparkling new Neurapheresis devices reach the market. ●
Medical Device Developments /
www.nsmedicaldevices.com
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