Boston Scientific Launches Live Cardiac Tissue Monitoring Technology DIRECTSENSE in U.S.

Boston Scientific

Medical device manufacturing company Boston Scientific is launching its DIRECTSENSE technology in the United States to help monitor cardiac tissue during radiofrequency ablation procedures. The technology was created for use in combination with the company’s RHYTHMIA HDx mapping system and the INTELLANAV MiFi open-irrigated ablation catheter. It works by measuring changes in the electrical impedance of tissue surrounding the catheter while being irradiated.

Currently, it is difficult to make adequate lesions that reduce the severity of cardiac arrhythmias while also preventing unwanted damage to the surrounding tissue during procedures. Doctors have to make estimations based on the patient’s anatomy along with any previous experience or knowledge from similar procedures. However, there is often over ablation or insufficient ablation, which may cause an arrhythmia or additional side effects.

Key highlights include:

  • Boston Scientific launches DIRECTSENSE technology in the United States after a successful trial in Europe. The technology helps physicians monitor cardiac tissue during ablation procedures with radiofrequency energy by measuring changes in the electrical impedance of tissue near the tip of the catheter during ablation procedures.

  • The technology helps physicians avoid over or under ablation and also reduces possible side effects of the procedures to optimize the patient’s care. It’s difficult for physicians to make adequate lesions based on the severity of cardiac arrhythmias without proper knowing the condition of the surrounding tissues. The device is the first of its kind to help measure how cardiac tissue responds to radiofrequency energy during ablation procedures.

  • The technology comes after a rough period for Boston Scientific as they lost nearly 50 perfect of their business due to postponed elective procedures. The company was also affected by the rioting in Minneapolis due to the death of George Floyd and donated $2.5 million to anti-racism programs in support of its employees. To make up for lost revenue, the company stated that its employees took a 20% pay cut for three months while five top executives lost half of their pay for six months.

According to a Boston Scientific statement made by Doctor David J. Callans, professor of medicine at the Perelman School of Medicine at the University of Pennsylvania, knowing about any changes in impedance around the top of the catheter provides imperative information about the characteristics of local tissues and the progress of the lesion. He stated that unlike other products on the market, the DIRECTSENSE technology helps doctors evaluate pre-ablation tissue while also supporting a better understanding of how the procedure influences the tissue. This allows doctors to make minimal, predictable ablations with minimal side effects during the procedure.

According to the company’s announcement, data from the LOCALIZE clinical trial, which provided an analysis of the DIRECTSENSE technology and was presented by Doctor Ignacio Garcia-Balao, director of cardiovascular and cardiology surgery at the University of Navarra in Pamplona, Spain, at the Heart Rhythm Society 2020 Science, there was a local impedance decrease of ≥16.6 ohms with inter-lesion spacing of ≤ 6mm. The data showed a ≥ 98% positive predictive value of durable pulmonary vein block at three months paroxysmal atrial fibrillation patients.

About Boston Scientific’s DIRECTSENSE Technology

Boston Scientific is a medical device company that strives to change lives through medical solutions. They help improve the health of patients all across the globe. The company has been a leading medical provider for 40 years and advances science for life by providing a wide range of high-quality solutions that meet patient’s needs while reducing the cost of healthcare.

They are responsible for creating defibrillators, diagnostic equipment, mapping and navigation devices, pacemakers, catheters, brain stimulation systems, remote patient monitoring systems, stents, retrieval devices, and much more. Currently, the company has 40 offices across the world and employees approximately 27,000 people. They support healthcare providers, patients and caregivers, and medical devices and products.  

Boston Scientific launched their DIRECTSENSE technology in June 2020 as a tool to help measure the radiofrequency energy generated by the tip of an ablation catheter. The technology is available on the RHYTHMIA HDx mapping system and received approval from the United States Food and Drug Administration in April. It’s the only tool currently available to monitor changes in local impedances or electrical resistance generated by the end of the INTELLANAV MiFi open-irrigated ablation catheter, which provides doctors with unique information and additional therapy measures during the process.

Ablation is a type of treatment for patients who have cardiac arrhythmias. It requires a doctor to use a catheter to create lesions in the heart tissue and then destroy the tissue that causes the abnormal rhythms. The DIRECTSENSE technology provides doctors with information regarding the impedance around the tip of the catheter. This allows doctors to track how the surrounding heart tissue is responding to the radiofrequency energy before they start the procedure. During the ablation process, the device measures changes in impedance, which helps provide doctors with a better understanding of the tissue’s health and how the procedure will affect the tissues. The technology can be used to determine temperature change in the tissues, which reduces the risk of over ablation and unwanted side effects.

According to Doctor Kenneth Stein, chief medical officer and senior vice president of Boston Scientific’s Rhythm Management and Global Health Policy, the success seen with the DIRECTSENSE technology in Europe allowed the company to introduce the product to doctors and their patients in the United States. Stein noted that this launch is an exciting milestone for growing their electrophysiology portfolio. It also provides physicians with a more direct understanding of lesions and provides them with efficient data to optimize their patient’s experience and results.

DIRECTSENSE Breathes New Life into Boston Scientific During Challenging Times

The launch of the new technology in the United States is exciting news for the company, especially after a tough year. Like many other medical devices companies that are affected by the postponement of elective surgeries due to COVID-19, Boston Scientific lost nearly 50% of its business. To cope with the loss of business, the company had to cut costs quickly but did not want to layoff employees. On April 2, the company reduced the wages of a large portion of its 36,000+ employees by 20 percent for three months. They also cut the salaries of five key executives in half for six months.

As many elective surgeries started to pick up again, the company ended its four-day workweek and pay cuts. However, top executives will continue to receive smaller paychecks until October. Mike Mahoney, the company’s CEO, had a base salary of almost $1.28 million in 2019. However, with stock and other payments, his pay was more than $15.7 million. Mahoney, who became CEO in 2011, stated that the pandemic has not been the company’s only challenge.

The company has a market value of over $48 million with locations on six continents with about 9,000 people working in Minnesota, which is approximately three times the amount of employees in Massachusetts. Most employees in Minnesota work in the suburbs of Minneapolis at one of the two campuses. In May, when George Floyd was killed by a Minneapolis police officer who knelt on his neck, riots broke out in the area where many Boston Scientific workers live. The company put five employees and their families in hotels to keep them out of harm’s way. They also provided grief counseling to workers.

Mahoney and other executive members held a Zoom call with 350 employees around the world to address racism in the workplace. The company promised to donate $2.5 million to anti-racism support programs. They also contributed $250,000 to the Greater Twin Cities United Way. However, Boston Scientific was not the only medical device company to feel the financial effects of postponed elective procedures. Other companies lost 50% to 80% of their revenue, including Stryker, Abbott, and Medtronic.

According to Wall Street analyst Vijay Kumar, the pandemic was like an Armageddon to these companies as hospitals did the unthinkable and stopped procedures. The effects of the pandemic were especially hard hitting for Boston Scientific. The company, which was founded in 1979, makes a wide variety of medical devices. However, approximately 70% of the devices are made for deferrable or elective procedures. As the pandemic has put on hold all procedures that are not an emergency, Boston Scientific has felt the financial impact. The success of the DIRECTSENSE technology in Europe has been a breath of fresh air for the company, who has struggled recently. As the technology will now be launched in the United States, the company looks to brighter days.

Boston Scientific is continuing the expansion of its electrophysiology department with the CE Mark for the POLARX Cryoablation system. It plans to launch this new product and start enrolling patients in Europe in a post-approval survey with the device within the next few months. The single-shot therapy, as well as the new technology from DIRECTSENSE, confirms the company’s desire to provide advanced tools and medical systems for patients who suffer from atrial fibrillation, which occurs when a person experience an irregular heartbeat. The condition may lead to stroke, heart failure, blood clots, and other heart-related problems.