Category Archives: stents

Where will medicine be 20 years from now?

My answer (edited) from this question on Quora.

I can speculate on this from the perspective of clinical practice and medical technology, but it should be first noted that another, important determinant of “where medicine will be” is the set of dynamics and forces behind healthcare delivery systems, including primarily the payment method, especially regarding reimbursement. It is clear that some form of reform in healthcare will result in a consolidation of the infrastructure paying for and managing patient populations. The infrastructure is bloated and expensive, unnecessarily adding to costs that neither the federal government nor individuals can sustain. This is not to say that I predict movement to a single payer system — that is just one perceived solution to the problem. There are far too many costs in healthcare that offer no benefits in terms of quality; indeed, such costs are a true impediment to quality. Funds that go to infrastructure (insurance companies and other intermediaries and the demands they put on healthcare delivery work directly against quality of care. So, whether it is Obamacare, a single payer system, state administered healthcare (exchanges) or some other as-yet-unidentified form, there will be change in how healthcare is delivered from a cost/management perspective.

From the clinical practice and technology side, there will be enormous changes to healthcare. Here are examples of what I see from tracking trends in clinical practice and medical technology development:

  • Cancer 5 year survival rates will, for many cancers, be well over 90%. Cancer will largely be transformed in most cases to chronic disease that can be effectively managed by surgery, immunology, chemotherapy and other interventions.
  • Diabetes Type 1 (juvenile onset) will be managed in most patients by an “artificial pancreas”, a closed loop glucometer and insulin pump that will self-regulate blood glucose levels. OR, stem cell or other cell therapies may well achieve success in restoring normal insulin production and glucose metabolism in Type 1 patients. The odds are better that a practical, affordable artificial pancreas will developed than stem or other cell therapy, but both technologies are moving aggressively and will gain dramatic successes within 20 years.
  • Diabetes Type 2 (adult onset) will be a significant problem governed by different dynamics than Type 1. A large body of evidence will exist that shows dramatically reduced incidence of Type 2 associated with obesity management (gastric bypass, satiety drugs, etc.) that will mitigate the growing prevalence of Type 2, but research into pharmacologic or other therapies may at best achieve only modest advances. The problem will reside in the complexity of different Type 2 manifestation, the late onset of the condition in patients who are resistant to the necessary changes in lifestyle and the global epidemic that will challenge dissemination of new technologies and clinical practices to third world populations.
  • Cell therapy and tissue engineering will offer an enormous number of solutions for conditions currently treated inadequately, if at all. Below is an illustration of the range of applications currently available or in development, a list that will expand (along with successes in each) over the next 20 years.
  • Gene therapy will be an option for a majority of genetically-based diseases (especially inherited diseases) and will offer clinical options for non-inherited conditions. Advances in the analysis of inheritance and expression of genes will also enable advanced interventions to either ameliorate or actually preempt the onset of genetic disease.
  • Drug development will be dramatically more sophisticated, reducing the development time and cost while resulting in drugs that are far more clinically effective (and less prone to side effects). This arises from drug candidates being evaluated via distributed processing systems (or quantum computer systems) that can predict efficacy and side effect without need of expensive and exhaustive animal or human testing.
  • Most surgical procedures will achieve the ability to be virtually non-invasive. Natural orifice translumenal endoscopic surgery will enable highly sophisticated surgery without ever making an abdominal or other (external) incision. Technologies like “gamma knife” and similar will have the ability to destroy tumors or ablate pathological tissue via completely external, energy-based systems.
  • Information technology will radically improve patient management. Very sophisticated electronic patient records will dramatically improve patient care via reduction of contraindications, predictive systems to proactively manage disease and disease risk, and greatly improve the decision-making of physicians tasked with diagnosing and treating patients.
  • Systems biology will underlie the biology of most future medical advances in the next 20 years. Systems biology is a discipline focused on an integrated understanding of cell biology, physiology, genetics, chemistry, and a wide range of other individual medical and scientific disciplines. It represents an implicit recognition of an organism as an embodiment of multiple, interdependent organ systems and its processes, such that both pathology and wellness are understood from the perspective of the sum total of both the problem and the impact of possible solutions.


There will be many more unforeseen medical advances achieved within 20 years, many arising from research that may not even be imagined yet. However, the above advances are based on actual research and/or the advances that have already arisen from that research.

Reference reports in Ophthalmology, Coronary Stents and Tissue Engineering

MedMarket Diligence has added three previously published, comprehensive analyses of  medtech markets to its Reference Reports listings. The markets covered in the three reports are:

  • Ophthalmology Diagnostics, Devices and Drugs (see link)
  • Coronary Stents: Drug-Eluting, Bare, Bioresorbable and Others (see link)
  • Tissue Engineering, Cell Therapy and Transplantation (see link)

Termed “Reference Reports”, these detailed studies were initially completed typically within the past five years. They now serve as exceptional references to those markets, since fundamental data about each of these markets has remained largely unchanged. Such data includes:

  • Disease prevalence, incidence and trends (including credible forecasts to the present)
  • Clinical practices and trends in the management of the disease(s)
  • Industry structure including competitors (most still active today)
  • Detailed appendices on procedure data, company directories, etc.

Arguably, a least one quarter of every NEW medtech report contains background data encompassing the data listed above.  Therefore, the MedMarket Diligence reports have been priced in the single user editions at $950 each, which is roughly one quarter the price of a full report.

See links above for detailed report descriptions, tables of contents, lists of exhibits and ordering. If you have further questions, feel free to contact Patrick Driscoll at (949) 859-3401 or (toll free US) 1-866-820-1357.

See the comprehensive list of MedMarket Diligence reports at link.

 

New Surgical Techniques Drive Market Opportunity

In cardiovascular and spine surgery, multi-billion dollar markets were created from entirely new procedures between 1980 and 2000, with subsequent segmentation in later years, particularly as new minimally invasive procedures were developed towards the end of the 20th century. For example, in the cardiovascular arena the development of new procedures for angioplasty and bypasses in the late 1980s led to these procedures being performed in increasing numbers. This increase was driven by lowered risk associated with the new procedures, new product availability, and surgeon capability coupled with substantial changes in demographics caused by aging, lifestyle and economics. For example, it is estimated that approximately 20% of the over 80-year-old population suffers from some form of coronary heart disease in the United States, and the development of angioplasty procedures created a new preferable (to open heart surgery) treatment for this population.  (But even these innovations have continued to evolve, with angioplasty giving way to stents, which have given way to bioabsorbable stents, drug eluting balloons and other advanced medical technologies.)

New technologies are driving surgical practice to capitalize on more effective techniques, more expeditious procedures and better outcomes than ever before. Minimally invasive procedures (endoscopic, NOTES, interventional and others) and new products (devices, equipment, biomaterials) to facilitate the performance of high volume surgeries have radically transformed the definition of surgery.  It becomes academic to consider whether new technique drives new technology or the other way around.

Whereas in the United States there were 50,000 open heart surgery treatments in 1980, by 2007 there were 253,000 open heart bypass operations, 1.1 million cardiac catheterizations and 652,000 stent insertions. Surgical closure and securement products are routinely used in these procedures, and new techniques like those in the cardiovascular segment with associated new technologies are likely to arise in the next decade to create new market opportunities.

Another example of a new buoyant market segment is that of spine fusion (see link). Until the 1980s, spinal surgery focused on multi-level segmental fusion procedures to fuse together several vertebrae to decrease the chance of failure at the bone metal interface. Fixation methods using Harrington hook and rod systems, Luque rods, and wires were used to achieve fusion. These procedures are notable by their invasive nature; they are associated with significant trauma and require substantial rehabilitation care for successful outcome. They were therefore initially used only in extreme cases of congenital deformity and cases of extreme trauma and pain.

In the mid- to late 1980s, a number of manufacturers developed bone screws for use in combination with these hooks and rods, which improved the achievement of stability without requiring multi-level fusion, and the emergence of threaded fusion cages in the mid-1990s added to the surgeon’s treatment options, with resultant increase in fusion success rates. The market for these products grew from tens of millions in 1980 to a $2.4 billion world-wide market in 2000. We forecast that such new techniques will create new market opportunities in the medical devices market for improved adjunctive products for surgical closure and securement.


See "Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion Markets, 2010-2015", Report #S180.

And yet another coronary artery disease treatment option

Medgadget highlighted a new treatment option that is in clinical trials for the treatment of coronary artery disease, an ultrasound system to stimulate blood vessel formation in ischemic areas of heart muscle.

Extracorporeal Shockwave Myocardial Revascularization (ESMR) is under development by Medispec, a Germantown, MD, company. The technology in its Cardiospec system uses Extracorporal Shockwaves coupled with R-wave ECG gating to stimulate angiogenesis in ischemic areas of myocardium.  Like transmyocardial laser revascularization (loosely comparable), which stimulates the formation of new blood vessels in ischemic myocardium, the ESMR system employs single-pulse, high-pressure ultrasound waves that have been shown to increase blood vessel formation and result in increased myocardial perfusion.  

Medgadget notes that ESMR is designed to "complement existing therapies for myocardial ischemia such as nitrates, CABG or angioplasty, and to provide an alternative treatment option for those patients who are candidates for more invasive procedures".

For the sake of keeping track of the seemingly ever-expanding range of therapeutic options for coronary artery disease, MedMarket Diligence has produced the following treatment map and now has added ESMR to the map:

 

In reality, there are numerous complementary treatments for CAD, such that the available methods to "map" the alternatives (we are using the open source application, FreeMind) have limited ability to accurately represent the options visually.


MedMarket Diligence published the Worldwide Drug-Eluting Stent Market report #C245.

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

Company
Product
Regulatory 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.)

Angioplasty/Stenting Results Competitive with Bypass

Angioplasty and the use of drug-eluting stents are being compared to coronary artery bypass graft surgery in a study reported in the April 15 issue of the American Journal of Cardiology.  Due to the invasiveness of bypass surgery, which most often involves the use of a sternotomy and cardiopulmonary bypass (CPB), both of which are associated with morbidity that is markedly higher in older, frailer patients, angioplasty with stenting, as a catheter-based procedure performed on a beating heart requiring neither sternotomy nor CPB, has emerged as a very viable competitor to bypass and is progressively taking away patient volume in bypass caseload. 

From Medical News Today:

"With the advent of more minimally invasive heart procedures, the medical field is exploring additional options for treating patients beyond surgical standards," said Lee, an assistant professor of cardiology at the David Geffen School of Medicine at UCLA. "Studies such as ours will help us better understand the impact of these new procedures and their role as possible new treatment options."

The researchers performed a review of the literature and then analyzed mortality and risk factors in eight clinical studies comparing the two procedures. The clinical studies took place between 2000 and 2009 and involved more than 2,900 patients.

Researchers found that the risk of death or heart attack at one-year follow-up did not differ significantly between heart bypass surgery and angioplasty with drug-eluting stents. The risk of stroke was lower with stenting than with bypass surgery, but the risk of an artery re-clogging was significantly higher in patients receiving a stent.

"There are benefits and risks to both procedures and our analysis shows that for select patients, drug-eluting stenting may be a good alternative," Lee said. 

This study concurs in principle with other studies that have been performed indicating that bypass shows a nominal advantage in long term efficacy due to the incidence of restenosis associated with stents (even for drug-eluting stents), but for many patients angioplasty and stenting results are competitive with bypass, potentially even considering the need for repeat procedures.


Coronary stents — drug-eluting, bare metal, bioabsorbable — and other treatments for coronary artery disease are the subject of the MedMarket Diligence Report #C245, "Drug-Eluting, Bare Metal and Other Coronary Stents, Worldwide Market, 2008-2017."

Drug-eluting stents market continues to rapidly evolve, globally

The global market for coronary stents is estimated to be in excess of $7 billion and projected to be growing at 6% per year. With the average age of citizens in developed countries increasing, there is an increased need to provide medical care to the average citizen. As such, an aging population translates into increasing numbers of people needing medical therapy and increasing numbers of people who need more aggressive medical therapy due to the aging process. As the population of developed countries ages, the number of percutaneous coronary interventions (PCIs) required increases as well. Currently, the incidence of PCI procedures (sometimes referred to as percutaneous translumenal coronary intervention or PTCA) is increasing at a rate of 3%–5% worldwide. Today, the vast majority of PCIs involve the implantation of one or more coronary stents.

Until the advent of coronary stents, patients with cardiovascular blockages had little choice but to either keep a close eye on their disease (“watchful waiting” with or without accompanying pharmaceutical therapy) or undergo coronary artery bypass grafting (CABG). When angioplasty was developed by Andreas Gruentzig in 1977, patients were presented with the option to undergo angioplasty in an effort to open blocked coronary arteries. While short-term benefits were usually seen with balloon angioplasty, longer-term outcomes showed many arteries re-closing and requiring repeated intervention; up to 50% of angioplasty patients were found to require further angioplasty within six months. In an effort to reduce the frequency of patients requiring reintervention, scientists and clinicians developed stents that could be left behind to hold the artery open once the PTCA balloon was withdrawn. 

Drug-eluting stents (DES) were developed to release a drug (e.g., sirolimus or paclitaxel) intended to reduce the incidence of restenosis. From there, even more innovative products have been developed, such as bioactive stents or stents designed to attract a patient’s own endothelial cells to coat the stent (as in devices by OrbusNeich, Hexacath, and Miami Cardiovascular Innovations).

Other device developers have sought to create stents that will fully degrade and disappear over a period of weeks or months—of a score of companies in this area, Abbott Vascular, Biotronik and REVA Medical appear closest to market. Yet others seek to abandon the use of stents altogether, opting instead to pursue an angioplasty balloon that will leave the anti-inflammatory drugs behind without the accompanying stent, as with CE Mark approved devices by EuroCor (the DIOR catheter) and B. Braun Melsungen (the SeQuent Please catheter).

Because the ultimate therapy has not yet been found, many opportunities still exist for effective therapies to combat atherosclerosis. So far, coronary stents hold the most promise for effectively treating an aging population with an increasing incidence of coronary artery disease.

The global market for coronary stents has evolved through technology development, market introduction and even the temporary "scare" of late stage thrombosis that was suspected, but later largely diminished, in the use of DES.  The market continues to evolve with progressive adoption of DES and bare metal stenting technologies, penetration of coronary artery bypass grafting caseload by PCI/stenting and the emergence of novel stent technologies like bioabsorbables as well as drug-eluting balloons and other therapeutic options.  The market is also changing globally, with variability in adoption rates by region and country.

(One of the stent industry's most respected resources on the coronary stent market is the MedMarket Diligence report #C245, "Worldwide Drug-Eluting, Bare Metal and Other Coronary Stents, 2008-2017.")