Cardiovascular device market trends

Part
01
of six
Part
01

Innovative Device Launch Trends: Cardiovascular Stents Segment

New developments in coronary stent technology have so vastly eliminated adverse outcomes over the past few decades, so much so that many researchers now consider the testing of similar stent technologies to be somewhat impractical. Because adverse outcomes are so much harder to find these days, a huge number of study participants would be needed to prove one product's superiority over another. As the current market-leading coronary stents perform well and have comparable patient outcomes (within a percentage), the market has become very mature over the past few years, with products competing based on price more than on clinical data, implying that advancements in cardiac stent technology over the past few years are not significantly driving growth in the market.

Though there have been no “earth-shattering” advancements in cardiac stent technology over the past few years, stent manufacturers have recently introduced new stents that are smaller, thinner, and have more bioresorbable features. These newer developments have led to improved patient outcome rates and have sparked new hope that the entire stent can ultimately be made bioresorbable.

Stents are Now Less “Clunky”

  • The Resolute Onyx uses continuous sinusoid technology, which involves forming a single strand of cobalt alloy wire into a sinusoidal wave to construct a stent. To improve the radiopacity of the small stent on angiography, it has a new metal core inside the wire to make it more visible.
  • In heart angioplasty, doctors pass a balloon catheter across the area of artery obstruction, and the balloon is inflated to displace plaque and widen the artery. At the same time, a stent (also called a “scaffold”) is deployed to the obstruction site and inserted into the widened artery to “prop” the artery open.
  • Shortly following FDA approval, a pioneering California interventional cardiologist named Richard Schatz, MD, inserted two stents into a local man whose arteries were considered too small to use traditional stents. Dr Schatz said that blockages that used to be difficult or even impossible to clear could be treated with the updated stent technology.
  • Stent technology has since been further developed; however, in its day, the Resolute Onyx 2.0 made many more patients eligible for stents.

Stent Design is Streamlined Further

  • Upon its launch in the US, Abbott touted that the product had a highly specialized coating that decreases the chance that an artery will become re-blocked over time.
  • The stent was designed to successfully treat patients with more complex cardiac disease.
  • More complex forms of coronary artery disease are becoming more common because heart patients are living longer. About one-third of all coronary artery disease patients present with what doctors consider technically complex cases, according to the National Institutes of Health.
  • The Sierra stent was designed to ease the artery-crossing process, open arteries wider, and provide a seamless outer lining for smoother “pushability” through vessels.
  • Abbott's premier product became the new “darling” of stent technology, because even more people who were previously considered ineligible for stents could be treated without heart bypass surgery.
  • Further, the new stent and its impressive study outcomes made doctors more comfortable about treating patients with stents.

Keeping Up with the Joneses: Germany-Made Stent Launched in US

  • Less than a year after the Abbott stent prevailed as the premier coronary stent technology, a Berlin-based company named Biotronik got its Orsiro stent approved by the FDA. The new scaffold features bioresorbable polymer and thinner struts.
  • The polymer eventually dissolves, and the Orsiro’s thinner struts are associated with less damage to the vessel walls during and after stent insertions. Orsiro has the thinnest struts among all stents on the market.
  • Studies show that Orsiro has even fewer adverse patient outcomes than previously approved stents, and may help reduce the need for anti-platelet therapy that is typically required following angioplasty and stent insertion.
  • The Orsiro achievement, among other factors, has spread new enthusiasm for the possibilities of creating a stent that is entirely bioresorbable, as stents are not considered to have any further therapeutic benefits 9-12 months after insertion.


Part
02
of six
Part
02

Innovative Device Launch Trends: Vascular Grafts Segment

The demand for vascular grafts has increased due to the rising incidence of cardiovascular diseases combined with advancements made in the filed of healthcare. External organizations, like universities and healthcare providers, are making huge investments for better vascular care. The vascular graft market is projected to grow at an 8.1% CAGR between 2018 and 2023. Because of the rapidly developing global vascular grafts market, major players are entering the field and elevating the competition levels. Most of them are focusing on investing in R&D to launching innovative products and diversify their portfolios.

Innovative Product 1: DuraGraft

  • DuraGraft is an intraoperative vascular graft treatment that maintains endothelial function and structure, reducing the incidence and complications associated with graft failure, improving clinical outcomes.
  • DuraGraft improves clinical outcomes by providing an environment which protects against intraoperative Ischemic Reperfusion Injury.
  • DuraGraft is a clinically tested and approved treatment for preserving vascular grafts.
  • The DuraGraft vascular graft treatment significantly improves long-term outcomes in coronary artery bypass grafting (CABG) surgery by reducing the incidence and complications of graft failure.
  • DuraGraft has significantly improved clinical outcomes and has the potential to change the bypass surgery landscape.
  • DuraGraft enhances CABG outcomes by significantly reducing major cardiac events such as repeat revascularization by 43%, myocardial infarction by 31%, and MACE by 21%.

Company that developed it

  • Somahlution, a global biotechnology company based in Jupiter, FL is leading the development of products that reduce the burden of ischemia reperfusion injury in tissue grafting, organ transplant and other surgical indications


Innovative Product 2: Bioabsorbable Vascular Graft

  • Bioabsorbable Vascular Graft replaces the portion of a blood vessel that is clogged, connecting both ends of the vessel. As blood flows through the graft, its design helps regenerate new tissue.
  • The Bioabsorbable Vascular Graft promotes cell attachment and cell proliferation to enable the regrowth of new blood vessel.
  • Bioabsorbable Vascular Graft is the first ever bio-absorbable vascular graft developed and patented in the US.
  • Bioabsorbable Vascular Grafts will be used to displace more commonly-used treatments, such as bypassing clogged arteries with other blood vessels or using a synthetic stent or graft.
  • Cardiovate’s differentiator is that its graft gradually dissolves after forming new tissue.

Company that developed it

  • Cardiovate, a start up based in San Antonio, TX, is a medical technology company that targets transformation health care opportunities in tissue regeneration and repair.

Research Strategy

An extensive search was done on vascular grafts. Vascular grafts (also called vascular bypass) are a surgical procedure that redirects blood flow from one area of the body to another by reconnecting the blood vessels. Vascular grafting is most commonly done to bypass a complete or partial blockage in an artery in order to improve blood flow to the organ or extremity supplied by the diseased artery. The main categories of vascular graphs are biological or synthetic.

While there are many factors favoring the expansion of the vascular grafts market, it still has to overcome certain obstacles. The main concerns are the high cost of surgeries required to treat vascular disorders and low reimbursement policies. The other major roadblock is the fear of vascular graft infection. Although rare, the possibility of occurrence of vascular graft infections instills an element of distrust among the afflicted.

Notable companies in the US vascular graft market include Cardinal Health (US), Gore Medical (US), C. R. Bard (US), LeMaitre Vascular (US), Endologix (US), and Cook Medical (US). The US dominates the global vascular graft market and is anticipated to maintain its dominance over the assessment period.


Part
03
of six
Part
03

Innovative Device Launch Trends: Prosthetic Heart Valves Segment

Some product launch trends that are driving growth in the prosthetic heart valves segment of the cardiovascular device market include the developments of Transcatheter Aortic Valve Replacement (TAVR) devices and Perceval sutureless aortic heart valve devices.

Trend #1: Development of TAVR Devices

  • TAVR devices work by delivering a "fully collapsible replacement valve to the valve site through a catheter." It pushes the old valve leaflets out of the way after the new valve is expanded. The replacement valve tissues then start regulating the flow of blood.
  • TAVR devices are innovative because they are repositionable and retrievable systems that replace narrowed aortic valves that fail to open properly.
  • TAVR devices are expected to change the prosthetic heart valves segment as the device market is expected to grow to approximately $4.45 billion globally at a compound annual growth rate (CAGR) of 11.4% in 2020, with $1.53 billion being derived from the United States.
  • Medtronic and Edwards Lifesciences initially developed TAVR devices. Direct Flow Medical and Boston Scientific are also developing the devices currently.

Trend #2: Development of Perceval Sutureless Aortic Heart Valve Devices

  • Perceval sutureless aortic heart valve devices work by replacing "diseased valves or malfunctioning prosthetic aortic valves." They facilitate minimally invasive cardiac surgeries that decrease the cardiopulmonary bypass and aortic cross-clamping.
  • Perceval sutureless aortic heart valve devices are innovative because they are "highly versatile and suitable for a wide range of surgical approaches" that improve patients' outcomes.
  • Perceval sutureless aortic heart valve devices are expected to change the prosthetic heart valves segment by driving the market value to about $13 Billion US by 2024 at a CAGR of 9.5%. This can be attributed to people's lifestyle changes, unhealthy eating behaviors, reduced physical activitiy, increased stress, and minimal risks, among other factors.

Research Strategy

To identify the product launch trends that are driving growth in the prosthetic heart valves segment of the cardiovascular device market, we reviewed a range of industry publications, media articles, and expert discussion. The trends identified were those written about the most in industry-specific publications.

Part
04
of six
Part
04

Innovative Device Launch Trends: Pacemaker Segment

As the pacemakers market continues to expand (CAGR of 7.2%), medical device companies are working to maintain their foothold in the industry. A growing population with abnormal heart rhythm disorders, or arrhythmias, continues to drive demand and increase growth in the pacemakers segment of the cardiovascular device market. Advancements in technology are growing trends that have proven beneficial for business expansion.

Leadless Cardiac Pacemakers

  • An MRI compatible pacemaker was introduced as one of the breakthrough technologies in 2008 to reverse declining pacemaker purchasing trends. The Medtronic Revo MRI SureScan was the first FDA-approved MRI compatible pacemaker.
  • More recent advancements in technology include leadless cardiac pacemakers with a generator attached to leads which have shown success in treatment outcomes. These pacemakers are placed directly in the heart without the need for insulated wires (leads) in a surgical pocket.
  • Currently, two leadless pacemakers are available: the Micra transcatheter Pacing system (Medtronic) and the Nanostim Leadless Cardiac Pacemaker (St. Jude Medical). Leadless cardiac pacemakers market is expected to grow at a CAGR of 21.9% from 2018 to 2026.
  • Leadless pacemakers prevent the appearance of scars with pacemaker placement and reduces the risk of infections.

Wireless, App-Based Pacemakers

  • Wireless, app-based remote monitoring compatible pacemakers are also changing the market. The Abbott/St. Jude Medical Confirm was one of the first implantable monitors introduced that directly connects with a patient’s smartphone.
  • Medtronics recently launched a mobile app in January 2019 that links patients’ smartphones or tablets with either one of the four company’s pacemakers. This app allows pacemakers to directly relay heart health data to the patient’s mobile device. It also contains educational material to guide monitoring with the pacemaker.
  • Technological advancements have provided a more streamlined approach to care with improved compliance and outcomes. According to a retrospective analysis, patients of all ages, including older patients, were able to successfully use app-based remote monitoring and exhibited improved adherence.

Research Strategy

We initially analyzed market research reports for growing product trends within the pacemaker segment. We then scanned through analyst reviewed reports and identified advancements in technology that are currently contributing to expanded market growth. After determining probable segment trends, we looked for brands and companies at the forefront of these technologies. Brand sites and clinical studies provided additional insight on the use of these devices and evidence of growth in the pacemaker market, respectively.
Part
05
of six
Part
05

Cardiovascular Device Market Trends

Cardiovascular devices are devices used in the diagnosis and treatment of heart disease and related health issues. The market for such devices is dominated by the United States, due to the inherent wealth and population size of the nation as well as the high prevalence of cardiovascular disease (CVD) within the population. Trends that are contributing to the growth of this market are outlined below.

INCREASING CARDIOVASCULAR DISEASE IN AMERICANS

  • One of the simplest principles of consumerism is supply and demand. The demand for CVD devices within the United States is best illustrated by the fact the American College of Cardiology attributed over 800,000 deaths to CVD in 2017 alone. This makes CVD the leading cause of death within the United States.
  • That death rate produces the staggering statistic that one person dies from cardiovascular disease in the United States approximately every 40 seconds.
  • It is estimated that by 2030, more than 40 percent of the US population is expected to be living with some form of CVD. That is a 10 percent increase in prevalence from 2017. This growth in patient numbers is a simple yet significant contributor to the growth of the CVD device market. As a consequence, the financial cost of CVD in the US estimated to more than double from 2011 to 2025, from $320 billion to almost $649 billion, including the cost of CVD devices.
  • The growth in demand for CVD devices is best demonstrated by reviewing Medtronic's financial results. Medtronic is the world's largest stand-alone medical device business and cardiac or vascular devices account for 35% of its revenue. In 2017 sales growth for cardiac or vascular devices outpaced overall sales growth at the business with 5% to 3%.


INNOVATION IN CARDIOVASCULAR TREATMENT

  • As health providers target enhanced patient health outcomes, market necessity is driving demand for more effective and efficient CVD devices. This not only relates to the improvement of existing technology and devices but the expansion of the market for medical technology manufacturers for innovative and alternative device solutions.
  • One such trend is the increasing preference for transcatheter aortic valve replacement (TAVR) over surgical aortic valve replacement. The viability of this form of treatment for patients whose traditional treatment plans may have included medication or open-heart surgery has led to growing payee acceptance and a 15 percent increase in average reimbursement. As this treatment option becomes more accepted and mainstream within the United States healthcare system it is growing the market size for CVD devices.
  • The increasing cost of treating patients with CVD is leading to an enhanced focus on the whole healthcare journey. Healthcare providers are now interested in a broad range of technology that supports patient monitoring, diagnosis, and therapeutic solutions. This provides medical technology manufacturers with the opportunity to develop and bring to market, devices for each stage of the healthcare lifecycle.
  • One such example is that of the Barostim Neo System that received U.S. Food and Drugs Administration approval in 2019. The device offers amelioration of symptoms in patients with advanced heart failure who are not suited for treatment with other devices, such as cardiac resynchronization therapy. The product is an implantable device that is extravascular. It stimulates approximately 40 times more frequently than a pacemaker and is complemented by a wireless programmer to tailor settings to a patient’s specific needs.


NEW MARKET ENTRANTS SURGE

  • The common wisdom is that new market entrants typically need to compete with established businesses in the sector to acquire custom at their competitors' expense. However, this is not being played out in the CVD device industry. Against the backdrop of an increasing number of end-users and desire for novel solutions the products being offered by new CVD device manufacturers are complementing the market rather than overcrowding it.
  • The CVD device market within the United States has historically been dominated by a select few behemoths. However, despite the overall market size growing from $36 billion in 2010 to $42 billion in 2016 the combined market share of the largest five businesses in this sector fell from 65% to 60%.
  • In contrast, the market share of 'others', a group of over 40 small-scale manufacturers grew from 22% to 26% in the same time frame. Whilst traditional giants of the industry still dominate the provision of established CVD products it appears challenger businesses have been able to succeed based on bringing innovative products to market.
  • One such notable example is the $50 million partnership between the American Heart Association (AHA) and Verily (a Google Life Sciences company) to support novel strategies for treating coronary heart disease which is due to complete in 2020. This project is the largest one-time research investment in AHA’s history and is a partnership that excludes a traditional medical technology company in favor of a small technology company.
Part
06
of six
Part
06

Innovative Cardiovascular Devices

Three innovative cardiovascular devices that could enter the market in the next 1-2 years are Medtronic's fully implantable left ventricular assist device, Edwards Lifesciences' interatrial shunt device, and Medtronic's Extravascular Implantable Cardioverter Defibrillator.

Medtronic's Fully Implantable Left Ventricular Assist Device

  • On October 29, 2019, Metronic received FDA's "breakthrough device designation" for its fully implantable left ventricular assist device (LVAD).
  • The fully implantable heart pump is being developed to replace the current solution for advanced heart failure, which is a heart pump that is implanted in the body, but is "connected to a driveline cable that extends outside the body to a controller, which is connected to power sources (AC or DC adapter, batteries)."
  • The new fully implantable LVAD would eliminate the need for external cables and power sources.
  • There is no estimated time of market entry; however, since the FDA designated the fully implantable heart pump as a breakthrough device, it will receive "priority review and interactive communication regarding device development and clinical trial protocols, through to commercialization decisions."
  • As of October 29, 2019, the device was in early-stage development. The average time it takes to get a device to market is between three and seven years, but with the breakthrough device designation, this time frame will likely be shortened.
  • This is an innovative product because it would be the first LVAD system on the market to be fully implanted in the body and not require external power sources. Additionally, the FDA named the pump as a breakthrough device, which is defined as "technologies that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions."

Edwards Lifesciences' Interatrial Shunt Device

  • Corvia Medical, which is backed by Edwards Lifesciences, received FDA's "breakthrough device designation" for its interatrial shunt device.
  • The interatrial shunt device is the "first transcatheter device for heart failure patients with preserved or mid-range ejection fraction."
  • Patients whose heart pumps between 40% and 50% of the blood in the left ventricle of the heart with each beat is said to have mid-range ejection fraction, but this segment of heart failure patients has been neglected when compared with other forms of heart failure.
  • Currently, treatment options for preserved or mid-range ejection fraction are limited, as drugs typically do not work well.
  • There is no estimated time of market entry; however, since the FDA designated the interatrial shunt device as a breakthrough device, it will receive expedited development, assessment, and review from the FDA. This will likely shorten the average three-to-seven years that it takes to get devices through the process and on the market.
  • This is an innovative product because there are few options to treat this specific condition, so the interatrial shunt device will treat more patients than can currently be treated. Additionally, the FDA named the shunt as a breakthrough device, which is defined as "technologies that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions."

Medtronic's Extravascular Implantable Cardioverter Defibrillator

  • In October 2019, Medtronic announced an expanded study to evaluate its Extravascular Implantable Cardioverter Defibrillator (EV ICD).
  • The EV ICD system is designed to "treat dangerously fast heart rhythms" by delivering "lifesaving defibrillation and pacing therapy via a device the same size as traditional, transvenous ICDs, but with a lead (thin wire) placed outside the heart and veins."
  • Currently, the only ICD systems are those that have leads inside the heart and veins, which increases the risk for the patient.
  • The estimated date of completion for this study so that the device can enter the market is December 31, 2022, which is a little longer than two years out.
  • This is considered an innovative product because the current device is risky to patients and the EV ICD has the "potential to deliver lifesaving ICD therapy without the risks associated with leads inside the veins and heart, and without compromising on the features available in traditional ICDs."

Research Strategy

After searching through clinical trials, company press releases, and medical journals, we were unable to find any devices from Medtronic, W.L. Gore & Associates, Boston Scientific, Abbott, or Edwards Lifesciences that are definitely expected to enter the market in the next 1-2 years. Therefore, we provided three examples of devices from these companies that have either received expedited status from the FDA or are currently holding trials that are expected to end at the end of 2022.
Sources
Sources

From Part 01
From Part 05
Quotes
  • "These devices are used to diagnose and treat heart disease and related health problems."
Quotes
  • "According to the American College of Cardiology, cardiovascular disease (CVD) accounted for 800,000 deaths in the United States in 2017 alone. Among Americans, an average of one person dies from cardiovascular disease, every 40 seconds."
  • "The United States dominates the cardiovascular devices market, owing to the high prevalence of cardiovascular disease, the high adoption rate of minimally invasive procedures, the presence of reimbursements, rising geriatric population, and the high demand for continuous and home-based monitoring."
Quotes
  • "Heart disease is the leading cause of death in the United States, affecting about 600,000 people each year.1 More than 85 million Americans are living with some form of cardiovascular disease or stroke, and by 2030, more than 40 percent of the US population is expected to have some form of CVD, a prevalence increase of 10 percent."
  • " the financial burden of CVD also is expected to grow, with the estimated direct cost of CVD in the US doubling from 2011 to 2025, an increase from $320 billion to nearly $649 billion (Figure 1).6 The market for CVD products is also expected to grow due to increasing prevalence of CVD"
  • "Innovative treatment technologies in CVD, such as transcatheter aortic valve replacement (TAVR) and 3D printing, are expanding the market for MedTech manufacturers. TAVR enables less-invasive treatment options, which may reduce hospital stays, positively impact patients, and improve health care system efficiency. "
  • "Over the next five years, global revenue from 3D printing in medical devices is expected to triple, from $0.8 billion in 2015 to $2.4 billion in 2020"
  • "The uptake of innovative treatment technologies, including TAVR and 3D printing, is creating new cardiovascular treatment options and expanding the MedTech CVD market. Providers are interested in—and MedTech companies should develop and offer—a wide spectrum of diagnostic, therapeutic, and monitoring solutions that providers can leverage to manage the patient journey"
  • "There is emerging evidence that some CVD programs built around digital solutions have resulted in benefits to both patients and providers. A 2015 study conducted by the Mayo Clinic found that digital health intervention for populations with early-stage CVD led to a 40 percent relative risk reduction and a 7.5 percent absolute risk reduction in CVD events, hospitalizations, and deaths."
  • "From the provider perspective, digital solutions can serve as clinical-decision support tools for providers inputting patient data to generate treatment recommendations.32 Moreover, there could be opportunities for significant in-hospital cost savings when providers leverage digital technologies"
  • "As technologies to treat cardiovascular disease continued to advance from 2010 to 2015, the top five global CVD players’ rankings shifted and their combined market share dropped five market share points, from 65 percent of a $36 billion global market to 60 percent of a $42 billion global market. And even though incumbents continue to own the market for traditional CVD products, the share of “others,” which includes new entrants, has been slowly growing"
  • "The profile of a typical cardiovascular provider is changing, the result of physicians increasingly switching from private practice to employment in provider networks, an aging workforce, and the impact of new care delivery standards on clinicians’ traditional roles"
  • "Finally, cardiovascular care increasingly is being provided by non-cardiologists. This trend includes shifting certain treatment activities, including prescription writing, from physicians to nurse practitioners (NPs) and physician assistants (PAs)—and the scope of allowed activities is growing"
Quotes
  • "The North America cardiovascular devices market is expected to reach US$ 27,058.9 Mn in 2027 from US$ 15,299.7 Mn in 2018. The market is estimated to grow with a CAGR of 6.7% from 2019-2027."
  • "The growth of the cardiovascular devices market is primarily attributed to the rising developments for cardiovascular devices and rising geriatric population.However, rigorous regulations for approval is likely to pose a negative impact on the market growth."
Quotes
  • "The U.S. Food and Drug Administration today approved the Barostim Neo System for the improvement of symptoms in patients with advanced heart failure who are not suited for treatment with other heart failure devices, such as cardiac resynchronization therapy. "
  • "The FDA gave the device a Breakthrough Device designation because it treats a life-threatening disease, heart failure, and addresses an unmet medical need in patients who fail to get adequate benefits from standard treatments and have no alternative treatment options."
Quotes
  • "BAROSTIM THERAPY™ is effectively administered through BAROSTIM NEO™, a minimally-invasive, long-lasting device. It is an implantable system that is extravascular. It is composed of a carotid sinus lead that is sutured on the carotid artery and connected to an implantable pulse generator (IPG). The IPG is inserted under the collar bone, stimulating approximately 40 times more frequently than a pacemaker. The system is completed by a wireless programmer system to tailor the therapy to the patient’s needs."
Quotes
  • "Medtronic is the world's largest stand-alone medical device company, with total sales in its last fiscal year, ended April 28th 2017, of US$29.7bn. "
  • "Cardiac rhythm disease management products accounted for around 19% of all sales at the company in the previous fiscal year, and all cardiac and vascular products just over 35%."
  • "Total revenue increased by 3% to US$7.4bn, partly owing to strong sales growth in markets outside the US. Sales of cardiac and vascular products increased by 5% while revenues from the minimally invasive therapies and restorative therapies segments rose by 3% and 2%,"