Michael F. Mahoney, Chairman and CEO
Daniel J. Brennan, Exec. VP and CFO
Kevin Ballinger, Exec. VP and President, Interventional Cardiology
Joseph M. Fitzgerald, Exec. VP and President, Rhythm Management
David A. Pierce, Exec. VP and President, MedSurg
Art Butcher, Sr. VP and President, Endoscopy
Jeff Mirviss, Sr. VP and President, Peripheral Interventions
Maulik Nanavaty, Sr. VP and President, Neuromodulation
NO. OF EMPLOYEES: 29,000
GLOBAL HEADQUARTERS: Marlborough, Mass.
Transcatheter aortic valve replacement (TAVR, also called TAVI—transcatheter aortic valve implantation) is one of the more exciting technologies to hit the market in recent years. The minimally invasive surgical procedure to replace a narrowed aortic valve that fails to open properly is a much safer option for higher-risk cardiac patients. Rather than cutting the chest open, the valve can be delivered via catheter through the femoral artery or a small incision in the chest through a large artery.
The TAVR market is poised to exceed $5 billion by 2021, according to Reuters. Edwards Lifesciences has long been considered the leader of this market. (Check out the full report on Edwards later in the Top Companies listing.)
However, the interventional cardiology market can be unforgiving for product missteps, as global medical device firm Boston Scientific learned as its Lotus range of TAVR devices struggled to perform and compete in the lucrative market.
For instance, last February, the company recalled its Lotus heart devices, citing issues with the locking mechanism—specifically, excess tension in the pin mechanism introduced during manufacturing. The Massachusetts-based firm had suspended European implants of its Lotus Edge TAVR in October 2016 due to similar concerns, though claimed last January that it had found a fix. Further, Boston Scientific delayed the submission of its marketing application for Lotus Edge in late 2016. The company had intended to submit the application last May, and receive an approval by the end of 2017. Analysts previously forecasted between $100 million and $125 million in 2017 global sales for Lotus devices. J.P. Morgan analysts predicted the short-term Lotus withdrawal would benefit Edwards’ 2017 revenues thanks to delaying the competitive threat.
Boston Scientific was also embroiled in patent litigation with Edwards over its Lotus Valve System at the time. The patent in question concerned the Lotus Valve Adaptive Seal, which creates an external seal to prevent paravalvular leak. Both the Patents Court of the High Court Justice of England and German District Court of Düsseldorf, however, ruled in favor of Boston Scientific. Edwards’ Sapien 3 device was determined to infringe on one Boston Scientific Scimed Inc. patent in the United Kingdom, and two German patents. The two companies continued to battle over TAVR patents this year. Boston Scientific has prevailed in the majority of European cases—culminating in the European Patent Office revoking an Edwards patent for Sapien 3. Edwards, however, came out on top in U.S. litigation. The U.S. Patent and Trademark Office determined Boston Scientific’s claims against Edwards patents were invalid.
As the year went on, Boston Scientific’s Lotus woes continued to deepen. Following the medical device maker’s sudden cancellation of an appearance at the annual Piper Jaffray conference last November, the company declared its Lotus Valve heart devices would not be marketed in the United States and Europe in early 2018 as planned.
Boston Scientific gave no reason for the delay, according to the Boston Business Journal. The company only said it “implemented manufacturing process and design specification changes to the Lotus Edge delivery system” following February’s recall.
“We continue to see value in the benefits of the Lotus Valve platform in treating patients with aortic stenosis,” CEO Mike Mahoney said in a statement. “While we are disappointed in this delay to our timelines, we are working to carefully analyze and implement necessary modifications to pass our rigorous internal quality standards.”
ANALYST INSIGHTS: After the Stryker acquisition/takeover “rumors,” it will be interesting what direction Boston Sci takes. It is no surprise that they remain an attractive target for the top OEMs in the med device world.
—Mark Bonifacio, Founder and President, Bonifacio Consulting Services
By the time markets closed the day Boston Scientific made the delay announcement, shares had plummeted 7.5 percent, slashing the company’s market cap from $39.1 billion to $36.2 billion.
Whatever worries Lotus’ mishaps gave investors, however, were assuaged upon the report of the company’s 2017 sales. Continuing its pattern of growth, Boston Scientific posted $9 billion of revenue last year, rising 8 percent from the year prior. Part of this is attributed to operational net sales of about $105 million derived from the acquisition of EndoChoice Holdings during the fourth quarter of 2016.
Boston Scientific’s Cardiovascular franchise is composed of Interventional Cardiology and Peripheral Interventions. The Interventional Cardiology portfolio consists of technologies for coronary artery disease and other cardiovascular disorders, including structural heart conditions. The Peripheral Interventions franchise consists of products to diagnose and treat peripheral arterial diseases, including devices used in percutaneous transluminal angioplasty (PTA) and peripheral vascular diseases. The segment also includes products to diagnose, treat, and ease various forms of cancer.
Despite Lotus’ failings, the Interventional Cardiology franchise rose 6.1 percent from the previous year to garner $2.4 billion in 2017 sales. The modest increase primarily resulted from sales of the Watchman left atrial appendage closure technology, growth in complex percutaneous coronary interventions product offerings, and last May’s acquisition of Swiss structural heart company Symetis SA.
The purchase of Symetis for a cool $435 million helped Boston Scientific further penetrate the TAVR/TAVI market it is so eagerly pursuing by adding to its portfolio the Acurate TA and Acurate neo/TF valve systems to treat high-risk patients with severe and symptomatic aortic valve stenosis. These devices are already sold in Europe and other area outside the United States, and the Acurate TAVI platform is recognized for ease of use during valve implantation.
“The steps we are taking reflect our commitment to being a leader in TAVI and structural heart technologies now and over the long-term, as we broaden our portfolio and pipeline to address the needs of our global healthcare providers and their patients,” said Ian Meredith, M.D., executive vice president and global chief medical officer of Boston Scientific. “The Acurate family of valve products is strongly complementary to our cornerstone Lotus valve platform, and this compelling combination of technologies will allow us to provide interventional cardiologists and cardiac surgeons with multiple TAVI offerings for varying patient pathologies and anatomy.”
Though the transaction was immaterial in 2017, Boston Scientific expects it to be slightly accretive this year as the company integrates Symetis into its Interventional Cardiology business.
Peripheral Interventions products generated $1.1 billion in sales, rising 6.8 percent from the year prior. The year-over-year increase was largely provoked by growth in the company’s core franchises—in particular, the stent portfolio, drug eluting products, and atherectomy (removal of plaque from blood vessels) systems.
Boston Scientific’s Rhythm Management business consists of Cardiac Rhythm Management (CRM) products—implantable devices to monitor the heart and deliver electricity to treat cardiac abnormalities—and Electrophysiology—less-invasive medical technologies for diagnosis and treatment of heart rate and rhythm disorders, including a broad portfolio of therapeutic and diagnostic catheters and a variety of equipment used in the Electrophysiology lab.
CRM products spawned $1.9 billion of revenue, growing 2.5 percent, and was fueled by growth in defibrillators and pacemakers. Continued Emblem S-ICD sales stimulated defibrillator sales expansion, as did the European launch of the Resonate family of ICDs (implantable cardioverter defibrillators) and CRT-Ds (cardiac resynchronization therapy defibrillators) and favorable impact from U.S. MRI-safe conditional labeling approved by the FDA last September. Pacemaker growth came as a result of the annualized impact of the company’s U.S. MRI pacemaker launch in the first half of 2017.
ANALYST INSIGHTS: Mike Mahoney—CEO (voted the 2nd most liked CEO in the US in 2018!) has done an excellent job of positioning BSC as a leader in the medical device industry, specifically in Cardio and Vascular therapies. The good news/bad news is that it does now make BSC a potential target for a larger strategic to acquire. In the meantime, watch for BSC to continue to be aggressive in its core markets.
—Dave Sheppard, Co-Founder and Principal, MedWorld Advisors
Following last February’s European launch, the Resonate ICDs and CRT-Ds gained FDA approval last May. Resonate devices feature SmartCRT technology with Multisite Pacing capability for multi-electrode pacing, and are also compatible with the HeartLogic heart failure diagnostic service to help clinicians improve heart failure management. Further, Resonate devices are powered by battery technology with nearly two times the usable capacity as a number of competitive devices—one of which, according to internal research, is Medtronic’s Evera XT VR. Boston Scientific also initiated a series of clinical trials to demonstrate improved response to CRT therapy using the proprietary SmartCRT technology to help physicians optimize where, when, and how to pace the lower heart chambers.
Additionally, the U.S. launch of the Resonate portfolio accompanied last September’s FDA approval of MR-conditional labeling for high-voltage devices. The MRI-safe capability extends beyond the Resonate devices; patients previously implanted with Autogen, Dynagen, and Inogen ICDs and CRT-Ds can now receive full-body MR scans in 1.5 Tesla environments under correct conditions of use.
Electrophysiology sales ballooned 14.5 percent to reach $278 million, driven by stronger sales of the Rhythmia Mapping System, Rhythmia HDx, Rhythmia related disposables, and expanding arsenal of navigation-enabled therapeutic catheters. To further bolster the business, last October, Boston Scientific also entered negotiations to purchase Apama Medical for up to $300 million.
Campbell, Calif.-based Apama Medical added the Apama Radiofrequency (RF) Balloon Catheter system to treat atrial fibrillation to Boston Scientific’s Electrophysiology franchise. The Apama RF balloon is a single-shot, multi-electrode technology that combines the benefits of RF point-by-point and balloon-based ablation approaches, particularly by delivering differentiated levels of energy and shortened procedure times. Built-in digital cameras with LED lights and sensing electrodes on the balloon provide real-time visualization and catheter electrode contact assessment. The Apama RF balloon is currently being studied in European clinical trials.
The MedSurg division consists of the Endoscopy, Urology and Pelvic Health, and Neuromodulation franchises. The Endoscopy business develops and manufactures devices to diagnose and treat a broad range of gastrointestinal and pulmonary conditions with less invasive technologies. The Urology and Pelvic Health business makes devices to treat various urological and pelvic conditions for both male and female anatomies, including kidney stones, benign prostatic hyperplasia, erectile dysfunction, male incontinence, pelvic floor disorders, abnormal uterine bleeding and uterine fibroids and polyps. The Neuromodulation segment touts devices to treat various neurological movement disorders and manage chronic pain.
Endoscopy products garnered $1.6 billion in 2017, escalating 12.4 percent from the year prior. The expansion resulted from healthy performance of the hemostasis franchise featuring the company’s Resolution 360 clips, the biliary franchise with the SpyGlass DS Direct Visualization system, and infection prevention offerings gained from EndoChoice. In 2017, Boston Scientific substantially completed integration of EndoChoice into the Endoscopy portfolio.
The Urology and Pelvic Health business rose 11.8 percent from the previous year to garner $1.1 billion in 2017 revenue. Growth of sales in kidney stone products (particularly the LithoVue Digital Flexible Ureteroscope), pelvic floor products, and men’s health products were largely responsible for the expansion. Further, a competitor that exited the market in 2016 provided Boston Scientific with share gains in the urology and pelvic health market.
The Neuromodulation franchise’s sales swelled 14.2 percent to $635 million. The growth was derived from the continued adoption of the company’s Precision Montage and Precision Spectra with MultiWave technology spinal cord stimulation systems in the United States, as well as heightened international sales. A number of regulatory approvals within the Vercise deep brain stimulation (DBS) product line also contributed to growth within this area.
DBS therapy involves placement of a device to stimulate specific brain areas with electrical signals. The Vercise Gevia DBS system earned CE mark approval last June. With a 25-year battery life, the rechargeable, MR-conditional device is intended to treat movement disorder symptoms in patients with Parkinson’s disease, dystonia, and essential tremor. The system also features programming software that lets clinicians visualize how stimulation will be distributed in the brain while configuring patients’ DBS stimulation programs. Usually, physicians chiefly rely on patient feedback to complete the program, but the software provides another source of information.
The Vercise DBS system to treat Parkinson’s disease achieved FDA approval last December. First launched in Europe in 2012, it was developed from cochlear implant technology. The Vercise IPG (implantable pulse generator) is currently the smallest rechargeable DBS device available in America. In the landmark VANTAGE study, 40 patients treated with the Vercise DBS system demonstrated a 63 percent improvement in motor function at 52 weeks from baseline as measured by the Unified Parkinson’s Disease Rating Scale III, as well as improvements in quality of life and medication usage.
“This approval marks an important step for patients who will now have the choice to be treated with one of the most innovative neuromodulation technologies available today,” said Maulik Nanavaty, Boston Scientific’s president and senior vice president of Neuromodulation. “Our system stands apart from the field in its approach and is changing the traditional definition on how we can leverage technology to treat patients with Parkinson’s disease.”