Stents are Now Less “Clunky”

• The introduction of the Medtronic Resolute Onyx 2.0 stent after FDA approval in February 2018 gave doctors the smallest-sized drug-eluting stent that had ever been created.

• 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

• Shortly after the Resolute Onyx was approved, the US government in May 2018 approved Abbott Laboratories’ Xience Sierra cardiac stent, which was thinner, had longer "arms" and greater flexibility.

• 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.

• Studies of the device generated an unprecedented safety record for reducing thrombosis. Arterial thrombosis can lead to a heart attack.

• 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.

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

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.

• The devices were initially developed by LivaNova, which has one of its operating headquarters in Houston, United States.

Research Strategy

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

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.

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