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Drug-Eluting Balloons: Promise Versus Practicalities

This article was originally published in Start Up

Executive Summary

Drug-eluting balloons might someday pick up where drug-eluting stents leave off, promising to solve problems not addressed - and even created - by DES. However, despite what interventional cardiology companies have learned about device and drug combinations, the drug-coated balloon markets aren't as simple as they might at first seem. Device companies will have to get conversant with issues that are more closely akin to the pharmaceutical industry than the device world, namely, how the products perform in terms of pharmacokinetics and drug distribution.

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Drug-Coated Balloons Fuel Multibillion-Dollar Hopes

With a total market potential estimated in the multibillion-dollar range, the drug-coated balloon opportunity is attracting a growing list of competitors, including several leading multinational cardiovascular device companies that have entered the space via recent acquisitions. DCBs still need to prove their worth in large, long-term clinical trials, but the ultimate proving point for DCBs could center on cost: if they can offer an effective treatment option that is significantly less expensive than existing devices, DCBs may provide a compelling economic argument.

Lutonix: Back To The Future With Drug-Coated Balloons

Drug-coated balloons were once thought to be an unnecessary innovation because of drug-eluting stents. With DES no longer seen as the panacea for vascular disease, balloons could re-emerge as the next major technology platform, and Lutonix is leading the race to bring them to the US market.

Is Therapeutic Hypothermia Finally Heating Up?

Therapeutic hypothermia companies have largely been disappointing for investors who poured in -- and lost -- fortunes investing in promising cooling technologies. But while many first-generation start-ups no longer exist, the technologies they developed live on within the large corporations that paid pennies on the dollars to acquire them. Although the pioneers in the field failed to meet their objectives, there is reason for hope. Their corporate acquirers have continued to move the technology down the field. The end zone may not be in sight, yet, but advancement is slow and steady. Meanwhile, medical societies including the American Heart Association have issued guidelines on how hospitals should employ therapeutic hypothermia in treating patients. Similarly, some decision makers - including the City of New York - are requiring patients be taken to facilities that offer cooling treatments, giving the field the legitimacy it lacked for so long. Finally, innovation is beginning to take root again as new start-ups develop a next generation of therapeutic hypothermia devices. Taken together, these developments suggest that patient temperature management may arrive someday soon.

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