The medical devices industry remains one of the fastest-growing high-technology industries globally. While an increasingly ageing population, awareness, affordability and access have been the traditional market drivers fuelling its growth, technological advances such as minimally invasive surgery (MIS) and drug-device combinations are further powering the sector.
Technological advances are boosting treatment outcomes, ensuring that surgeons and patients are confident and fully aware of the health benefits these devices have to offer. Here we profile ten of the revolutionary technologies in the market or in development. We'll identify ten more next issue.
1. Total artificial heart
An artificial heart is a mechanical device that is implanted into the patient's body to replace the two lower chambers of the biological heart. An artificial heart has become a reality with increased knowledge of the heart and its functions and continuing improvements in prosthetics engineering, information technology, electronics and battery technology. One company, SynCardia Systems, is marketing the Cardiowest™ total artificial heart.
On 27 October 2008, French professor and leading heart transplant specialist Alain F Carpentier announced that a fully implantable artificial heart will be ready for clinical trials by 2011 and for alternative transplant in 2013. Biomedical firm Carmat, venture capital firm Truffle and Professor Carpentier will be partners in developing and manufacturing the device. Another US team with a prototype called the MagScrew Total Artificial Heart is in a race to produce similar products.
2. Biologics delivery systems
Biologics delivery systems offer an alternative to combat ischemia and cardiac lesions. Advances in biotechnology are being used to develop technologies for this niche market segment. Cell therapies are aimed at administering progenitor cells to the heart to repair or reverse the effects of myocardial ischemia or injury. Surgical-based injections along with bypass surgeries were traditionally used for this purpose.
Catheter-based injection, such as the one Cordis Corporation has under trials, is less invasive and effective since the cells are delivered directly into the arterial walls at the place of lesions. Preliminary clinical trial results have shown that stem cell therapy has a high patient improvement quotient, in patients suffering from coronary diseases.
With the prevalence rates of coronary heart diseases and stroke as high as 10% of the world population and 30% of them unsuitable for coronary stenting procedures or bypass surgery, heart cell therapies have a potential market with a huge unmet need.
3. Hip resurfacing
Hip resurfacing is not new and had been in use in Europe, Japan and elsewhere long before it entered the US market. The first hip resurfacing implant was launched in the US just three years ago when the UK company Smith & Nephew received the US Food and Drug Administration's nod to sell the Birmingham Hip Resurfacing (BHR) system in May 2006.
Since its launch, hip resurfacing has been rapidly emerging as an alternative to hip replacement for younger patients aged 55 and under. The fact that hip resurfacing offers reduced pain, improved joint stability, greater range of motion post-surgery and lower risk of complications, is boosting its popularity over traditional hip replacement procedures.
GlobalData estimates that the US hip resurfacing market, valued at $57.3m in 2008, is forecast to grow by an average 36% annually during the next seven years to reach $483m by 2015.
4. Bioabsorbable stents
Bioabsorbable drug-eluting stent technology has caught the attention of coronary stent manufacturers, investors and technology experts because of the potential benefits it offers.
The technology has the potential to deliver an anti-proliferative agent to reduce restenosis and degrade/dissolve over a period of time to eliminate disadvantages related to non-biodegradable stents.
On 24 March 2009, Abbott Laboratories enrolled the first patient in Phase II of the ABSORB clinical trial. The company also announced the two-year results of the original 30 patients implanted with its novel bioabsorbable everolimus-eluting stent. The ABSORB Phase I trial demonstrated 0% blood clot formation, no major adverse cardiac events from six months to two years, complete and successful absorption of the stent and restoration of vasomotion. The device is at the clinical trial stage and is at least three years away from receiving marketing approval.
Favourable results demonstrated by bioabsorbable stents in recent clinical trials, if sustained over a period of five years, would redefine and add momentum to the relatively stable $5bn coronary stents market.
5. Remote patient monitoring
Remote patient monitoring (RPM) uses devices to collect vital health data and sends it to healthcare professionals based at a remote location – greatly minimising hospital stays and resulting in a reduction in the cost of healthcare delivery. RPM enables healthcare providers to monitor and diagnose health conditions by remotely collecting, storing, retrieving and analysing vital health signs.
For hospitals and other healthcare delivery settings, RPM greatly reduces patient load on available health resources by ensuring early discharge and by monitoring the progression of chronic diseases. It is not just the overcrowded hospitals that benefit from it. RPM enables patients to receive quality healthcare, staying at home, resulting in a much faster recovery. It prevents unnecessary trips to the emergency department and hospital readmissions.
GlobalData estimates that the global remote patient monitoring market, valued at $259.7m in 2008, is forecast to grow by over 5% for the next seven years to reach $375.6m by 2015.
6. Magnetic particle imaging
Magnetic particle imaging (MPI) technology uses the magnetic properties of iron-oxide nanoparticles injected into the bloodstream to generate real-time images of arterial blood flow and volumetric heart motion. MPI also uses the magnetic properties of the injected iron-oxide nanoparticles to measure the concentration of nanoparticles in the bloodstream. Because the human body doesn't naturally contain nanoparticles, by combining high spatial resolution with short image acquisition times, MPI technology captures dynamic concentration changes as the nanoparticles flow along with the bloodstream.
In pre-clinical stages, the first 3D imaging results with this technology were announced by Philips in March 2009.
The company became the first in the world to demonstrate the use of MPI in producing real-time in vivo images that capture cardiovascular activities accurately and in real time. The company noted that by augmenting important functional details to the anatomical data obtained from conventional modalities like CT and MR, MPI technology has the potential to help in the diagnosis and treatment planning of major cardiovascular diseases like atherosclerosis and congenital heart defects.
7. Cardiac resynchronisation therapy
Cardiac resynchronisation therapy (CRT) has the ability to relieve congestive heart failure (CHF) symptoms by improving the coordination of the heart's contractions. More than 22 million people worldwide suffer from CHF. CRT devices can protect the patient from slow and fast heartbeats.
Defibrillators are implanted in patients with heartbeats faster than normal whereas pacemakers are implanted in patients with heartbeats slower than normal. CRT devices help to overcome the delay in electrical conduction of the heart and also in restoring the normal function of the ventricles. Defibrillators and pacemakers improve the quality of a patient's life and also result in the survival of patients with heart failure.
GlobalData estimates that the global cardiac resynchronisation therapy market valued at $2bn in 2008 is forecast to grow by over 7% annually for the next seven years to reach $3.2bn by 2015.
8. Liver assist devices
The concept of liver dialysis has generated new interest because of an increase in the wait period for liver transplants.
The functions of liver including blood purifications, glycogen breakdown, synthesis of cholesterol and vitamins are rapidly slowed during wait periods for liver transplant and later extend to the onset of multi-organ failure. Liver dialysis is a detoxification treatment for liver failure, similar to the process of haemodialysis. Liver dialysis devices provide a form of artificial extracorporeal liver support.
Apart from providing a patient with an effective bridge to transplant the device, these devices also avert respirator use, avoid or decrease days in the ICU, shorten length of stay in the hospital, postpone or obviate the need for transplant, or improve the likelihood of a successful transplant by stabilising the patient's health prior to surgery.
Globally, about 20 million individuals suffer from liver cirrhosis or liver cancer, about 500 million people are infected with chronic HBV infection and more than 10 million cases of liver failure occur every year. Of these liver failure cases, approximately 2 million patients die primarily because of a lack of donors.
The healthcare spending burden and the large number of patients waiting for a transplant are expected to be greatly reduced with the increasing use of liver assist devices.
9. Transcatheter heart valves
Transcatheter heart valves are a less invasive way to treat heart valve diseases and have been proven to be safe and effective in clinical trials. Transcatheter heart valve replacement is performed via a procedure similar to a balloon angioplasty. A heart valve in a balloon expandable stent frame is compressed onto a balloon catheter, inserted into the patient's circulatory system and expanded in the diseased valve.
The procedure may take one to two hours and the recovery period is less than a week. The less invasive nature of the procedure allows more valve disease patients to receive the treatment.
Each year, approximately 200,000 patients in the US need a new heart valve because they have severe aortic stenosis. Having a less invasive option provides an alternative to patients who meet the criteria for transcatheter heart valve replacement.
Neurostimulation was used in the 1970s for the treatment of Parkinson's disease. Due to excessive side effects it was discontinued later. Over the last five years neurostimulation has entered a renaissance period as the treatment potential the technology has to offer has been newly recognised. It is increasingly being recognised as the best treatment option for indications such as Parkinson's disease, Tourettes Syndrome, migraines, chronic pain and major depression.
GlobalData estimates that the global neurostimulation devices market valued at $1.2bn in 2008 is forecast to grow by 13.4% annually for the next seven years to reach $3bn by 2015.