The evolution of coronary artery revascularization treatments, markets

The evolution of treatments for coronary artery disease has historically been dynamic and, with the stakes still high for effective treatment and many different technologies in active development by medtech manufactures, that evolution will be continuing shift over the coming years. 

Setting aside, for the moment, the trends in coronary artery bypass graft surgery, encompassing beating heart and non-beating heart minimally invasive and/or robotic systems to accomplish coronary revascularization, a great many trends are in process in the more narrow (yet multi-billion dollar) market for angioplasty and stenting. (There is fairly clear evidence that bypass grafting has better long term outcomes, especially considering the much lower need for repeat procedures compared to angioplasty/stenting.)

The ability to address ischemic heart disease via an interventional procedure that involves femoral puncture, rather than sternotomy, is a primary reason why angioplasty has become so attractive (some might argue that 2 or 3 femoral punctures are still better than one sternotomy).  The advent of stenting, to reduce the need for repeat procedures, was a significant boon to angioplasty, and with the advent of drug-eluting stents, that need for repeat procedures took an even bigger drop.

Of course, the story (clinically or in market and technology development) does not end there (if the story even has an end), since there will always be a drive for better outcomes and lower cost, or both.  The interventional cardiology market is on a path to evolve through an era of bioresorbable stents, then possibly an era of drug-eluting balloons.  There are even some, like reknowned cardio device innovator Julio Palmaz, who believe that the future of stents is actually back in bare metal stents.

For now, the landscape of antirestenosis is sketched out in the following:

Coronary Stents and Selected Other Antirestenosis Devices

CompanyProductRegulatory status
Arthro KineticsCollagen matrixIn development
BiometRegainCE Mark; Japan study underway; IDE underway
Cambridge PolymerInjectable hydrogelIn development
ClarianceNucleoFilIn development
CryoLifeBioDiscCE Mark
DePuy SpineSINUX ANRCE Mark
Dynamic SpineIPDIn development
GentisDiscCellCE Mark filed
NuVasiveNeoDiscFDA cleared; CE Mark
Pioneer SurgicalNuBacCE Mark; IDE begun 2009
Replication MedicalNeuDiscPilot clinical studies
SpineWaveNuCorePilot clinical studies
StrykerAquarelleIn development
SynthesHydrafilIn preclinicals
TranS1PNRPilot clinicals in Europe started 2008; on hold in US.
Vertebral TechnologiesInterCushionFeasibility trial outside US 2010
ZimmerNewcleusPilot clinicals in Europe ongoing.

Source: "Drug-Eluting, Bare Metal and Other Coronary Stents Worldwide, 2008-2017". Report #C245, MedMarket Diligence, LLC

 

(One should also recognize that the dynamics that drive medtech markets vary from one part of the world to the next.  The coronary stent markets in China and Japan, for example, are governed by different market forces.)

Leave a Reply