Cardiovascular Medical Devices: The Latest Innovations

Cardiovascular diseases are the leading cause of death around the world today, killing upwards of 17 million people each year. In the US alone, more than $300 billion is spent each year to support research into cardiovascular diseases and their treatment. With countless researchers and scientists around the world striving to develop effective treatments. Some of the most significant advancements in medical technology today focus on the cardiovascular therapy group.

The efforts to combat these widespread conditions involve both the pioneering of cutting-edge medical technologies and the refinement of existing methods to reduce costs and increase access to reliable healthcare for patients around the world. Cardiovascular medical devices play a key role in making treatment available for more people than ever with the introduction of new designs and materials.

Much of the focus on new medical device innovations for cardiovascular diseases has been on the development of new, minimally invasive treatment options. Conventionally, many cardiovascular problems have required invasive surgeries that carried increased risks of complications and infection, along with only being possible in elaborate medical facilities under expert surgeons. This placed such treatments out of the reach of countless individuals around the world.

Minimally invasive treatments using innovative cardiovascular medical devices provide treatment for a much broader range of people. They reduce the risk of complications and infection. They can be carried out in simpler medical facilities by less experienced doctors. All of this serves to reduce the cost of treatments overall and improve patient outcomes.

These are some of the latest innovations in cardiovascular medical devices that are changing the landscape of cardiovascular care as we know it.

Cardiovascular Medical Devices Innovations

Smart Balloon Catheter systems

Balloon catheter systems have been used in cardiac ablation, a procedure that’s used to treat cardiac arrhythmias such as atrial fibrillation, atrial flutter, etc. Recent advances in this technology include the use of complex electronics and sensors that are able to deliver the ablative effect via laser or electrical stimulation, or by pulsed electric fields or by radiofrequency energy; read blood flow, and other hematologic data; sense pressure and temperature. In addition, the system is now available with flexible electrode actuators – which is extremely useful in micro-navigation. 

Endoscopic Vessel Harvesting (EVM) Systems

When a coronary bypass has to be performed, surgeons may decide to perform a vessel harvesting procedure. The bypass is performed to restore blood flow to the heart by ‘bypassing’ a blockage in the heart. The ‘bypass’ route is a blood vessel taken from the leg or arm and is grafted in to restore blood flow. Traditionally open surgery required a long incision and a lengthy procedure, but the latest advances enable surgeons to ‘harvest’ the blood vessel through a minimally invasive means, called the endoscopic vessel harvesting system. The demand for EVM technology is growing rapidly, being valued at $400M in 2020.

Stem Cell Therapy

Researchers published a study in The Lancet medical journal, according to which they treated 17 patients that had suffered heart attacks, by injecting stem cells into the heart of the patient. Once injected, the stem cells develop into new heart cells, repairing the damaged tissue. This procedure requires the use of a specialized medical device, namely a catheter, in order to assure precise and safe delivery of stem cells to the heart, utilizing a minimally invasive procedure rather than risk open-heart surgery.

Implantable Devices:

• Defibrillators
  Otherwise known as ICDs, Implantable Cardioverter Defibrillators are automated implants that detect abnormal heart rhythms. ICD’s deliver high-energy, low-energy, and pacing shocks to the heart. This means that ICDs can perform cardioversion, defibrillation. In some cases, also pacing of the heart. Implantable defibrillators act as a permanent safeguard against sudden life-threatening arrhythmias, which would otherwise result in acute heart conditions.

• LVAD
  A Left Ventricular Assist Device, is a device that is used in critical cases where congenital defects cause the heart to fail or suffer arrhythmias. Surgeons at Penn State Heart have successfully used the novel device since early 2021. The novel Ventricular Assist Device provides critical life support for the patient until a heart transplant can be performed. The device functions as a mechanical pump and prevents hemolysis and the formation of clots within the heart. Previous versions of the LVAD had drawbacks that the latest versions have overcome.

Wireless Devices

With major breakthroughs in surgical technology, the wireless surgical camera is one of the latest. This technology allows surgeons to drop the camera where the arthroscopy is to be performed. The camera can be controlled without the need for wires, cords or any other assisting device. The camera functions with laser-based lighting, designed specifically for the operating room. The technology is a first of its kind and has obtained FDA approval to start the final testing phase.

Soft Robot

Researchers at Harvard University in collaboration with Boston Children’s Hospital, have developed an innovative device that fits around the heart to help it beat. The device, described as a soft robot, resembles a sleeve that can be installed around the heart, which compresses and twists in sync with the patient’s nominal heartbeat. Its operation is predicted to augment cardiovascular functions that have been weakened due to previous heart failure. A differentiating factor of this soft robot compared to currently available cardiovascular medical devices serving a similar function, is that it does so indirectly, without coming into direct contact with the patient’s blood.

AI Predictive Algorithms

At first glance, an algorithm doesn’t fit the conventional notion of a cardiovascular medical device. However, international medical device regulations specifically recognize software as a medical device: to be used for medical purposes without being part of a hardware medical device.
Google’s health-tech subsidiary, Verily, uses large data sets of eye images in correlation with the patient’s health information, in order to develop a predictive algorithm for cardiovascular health based on a patient’s eyes. Such a medical device is Verily’s artificial intelligence algorithm that “promises to predict heart disease just by taking one glance at a patient’s eyes”. 

Imaging Innovations

Medical imaging is a vital component of cardiac treatment, making it possible to identify and diagnose conditions and plan procedures accurately. Advancements in medical imaging are being driven by the development of new technologies to generate images and advanced algorithms to analyze images with greater accuracy and precision.

The European Society of Cardiology’s Heart Failure Association highlighted the major shifts in the medical imaging landscape in a position paper. Some of the most significant developments have been the use of three-dimensional ultrasound imaging to allow for the accurate and precise evaluation of myocardial deformation. This field of echocardiography has seen leaps and bounds and shows no signs of slowing.

MRI technology is also playing a significant role, with new techniques that allow for the evaluation of heart tissue not just at rest but during stress as well. This opens the door to more robust assessments covering a wider range of potential cardiac issues. New X-ray methods are simplifying assessment as well, with some conditions now identifiable through simple chest X-rays. These methods identify calcification within coronary arteries without the need for expensive and often inaccessible CT scans.

A central focus of many advancements in cardiac imaging is to develop non-invasive options to replace invasive diagnostic methods. Recent research shows that MRI is a promising technology for identifying plaque in arteries without the need for invasive diagnostics. While there is still much work to be done, there is hope that MRI technology will allow for earlier heart disease warning sign detection in the future.

Tackling the Challenges of Innovation

It is not uncommon for a company to engage in the design and development of an innovative novel medical device, only to deal with prototype scaling and manufacturability issues along the way. So when designing an innovative medical device, it is imperative to work with an experienced manufacturing partner. This will safeguard your bottom line, and supply you with knowledge and information that will make your device manufacturable, cost-efficient, and effective. 

Quasar has been the manufacturing partner of choice for novel medical device companies around the globe, for more than 30 years. Get in touch with Quasar to discover how you can kick-start your new device or optimize your existing cardiovascular medical device projects.

Read more:

• 6 Interventional Cardiology Advancements to Follow in 2022
• How to Conduct an FMEA for a Disposable Medical Device
• The 4 Phases of Medical Device Product Development Lifecycle