Бостон Сайентифик корпорациясы: Медициналық құрылғылар өндірушісінің тарихы

U. S. based medical device company

Boston Scientific Corporation ("BSC"), headquartered in Watertown, Massachusetts and incorporated in Delaware, is a biomedical/biotechnology engineering firm and multinational manufacturer of medical devices used in interventional medical specialties, including interventional radiology, interventional cardiology, peripheral interventions, neuromodulation, neurovascular intervention, electrophysiology, cardiac surgery, vascular surgery, endoscopy, oncology, urology and gynecology. Boston Scientific is widely known for the development of the Taxus Stent, a drug eluting stent which is used to open clogged arteries. With the full acquisition of Cameron Health in June 2012, the company also became notable for offering a minimally invasive implantable cardioverter defibrillator (ICD) which they call the EMBLEM subcutaneous implantable defibrillator (S ICD).

Boston Scientific was formed June 29, 1979, in Watertown, Massachusetts, as a holding company for the medical products company, Medi Tech, Inc., and to position the company for growth in interventional medicine. Medi Tech was the brainchild of Itzhak Bentov, a Czech born emigré to Israel and then to the United States, who worked at the Arthur D. Little think tank in Cambridge, Massachusetts, and ran a contract research company from his rented house in Belmont, Massachusetts, a venture he founded in 1965 with a business friend, Dan Singer. In 1967 he was asked by Boston Beth Israel Hospital radiologists to design a steerable, remotely controlled catheter; a series of engineering designs, polymer improvements and prototypes led to the release of a new steerable angiography catheter in 1969. That year John Abele joined the small company with an option to buy, and a year later he exercised his option with Cooper Labs as a business partner, and the operation was moved – out of Bentov's lab in the basement of the rectory of a Catholic church in Belmont – to Watertown. After a decade of steady growth, by chance Abele met Pete Nicholas in their neighborhood in Concord, Massachusetts. Their partnership hinged on Nicholas' goal to build business enterprises and Abele's predilection for the vision and potential in noninvasive surgical instrumentation; they gathered backers in the Boston banking community to buy out the Cooper Labs interest and form the new corporation. Less than a year later Kimray Medical Associates (later Mansfield Scientific, Inc.) was acquired, adding vena cava filters and cardiac output computers to the product line. By 1982 a renovated mill building in Watertown was transformed into a manufacturing plant. Acquisitions continued, with Endo Tech (Microvasive, Inc.: gastrointestinal and pulmonary) in 1981 and then Van Tec (urology) in 1988, and an international presence was expanded. Mansfield Scientific, Microvasive, and Medi Tech merged into Boston Scientific December 31, 1988.

On May 19, 1992, Boston Scientific launched an initial public offering of 23.5 million shares, of which 18.8 million were offered in the U. S. and 4.7 million were offered outside the U. S. The initial offering amounted to 23% of Boston Scientific's outstanding stock. The opening price was $17 per share. Goldman, Sachs & Co. (lead) and PaineWebber Inc. were the underwriters and Abbott Laboratories held a 20% stake (23.5 million shares). The market capitalization was about $1.6 billion. The U. S. shares were listed on the New York Stock Exchange.

From 1995 through 1997, Boston Scientific increased its technology R&D and product offerings following several substantial acquisitions that included Cardiovascular Imaging Systems (intravascular ultrasound), SCIMED (cardiovascular), Vesica Medical (urology), Meadox (textile vascular prostheses), EP Technologies (cardiac ablation controllers), MinTec (abdominal aortic aneurysm grafts), Symbiosis Corporation (specialty medical product manufacture), and Target Therapeutics (on neurology). Boston Scientific acquired Target Therapeutics in a tax free stock swap for about $1.1 billion, more than 10 times Target's earnings, in contrast to the usual multiple of 10 times earnings. The Taxus Stent was approved in 2003 in Europe and other countries and, in the United States, by the FDA in March 2004. It was the second drug eluting stent approved in the United States. In April 2004 the company announced that it had exercised an exclusive option to acquire Precision Vascular Systems, Inc., as part of a series of agreements between Boston Scientific and Precision Vascular in 2002 – for an undisclosed sum. In June Boston acquired Advanced Bionics Corporation for $740 million in cash, plus earn out payments. In December Boston completed its acquisition of Advanced Stent Technologies, Inc., for $120 million payable in Boston Scientific stock, plus the possibility of future contingent payments. AST had been developing stent and stent delivery systems specifically designed to address the anatomical needs of coronary artery disease in bifurcated vessels. In April 2005, Boston exercised an exclusive option to acquire TriVascular, Inc., for an undisclosed sum and renamed it as Boston Scientific Santa Rosa Corporation, or BSSR. TriVascular was founded in January 1998 to develop less invasive medical devices and procedures for treating abdominal aortic aneurysms, but BSC discontinued its endovascular aortic repair (EVAR) program in 2006. Also, in April 2005, BSC announced it had exercised its option to acquire CryoVascular Systems, Inc., and its proprietary angioplasty device to treat atherosclerotic disease of the legs and other peripheral arteries. In June Boston Scientific announced that its wholly owned subsidiary, Nemo I Acquisition, Inc., had successfully acquired Salt Lake City based Rubicon Medical Corporation, with Rubicon became a wholly owned subsidiary of Boston Scientific. In March 2008, BSC sold BSSR to TV2 Holding Company of Santa Rosa. Terms of the sale include $30 million in cash paid at the closing to BSC and a warrant allowing BSC to purchase a minority interest in TV2.

In January 2006, the company announced an offer for its longtime competitor, Guidant, for $72 per share or $25 billion. The offer, however, was rejected. On April 21, 2006, BSC acquired Guidant for $27.2 billion. Guidant was split between BSC and Abbott Laboratories. Four years later, in 2010, when moving its heart rhythm business from its acquisition of Guidant, Boston Scientific eliminated 1300 jobs.

BSC has been assessed favorably by its employees. In Glassdoor annual Best Places to Work – Employee's Choice Survey, BSC earned scores of:
2018: #35 (of 100). 4.4 stars (of 5). 2019: #56 (of 100). 4.3 stars (of 5). 2022: #52 (of 100). 4.3 stars (of 5). The feedback for this survey is given by current and former employees. As of 2018, BSC had 43% women among its employees, 38% among management positions, and 23% among corporate top management positions (data for US workforce, as of 2018).

Beginning in 2003, Boston Scientific and Johnson & Johnson were involved in a series of litigations involving patents covering heart stent medical devices. Both parties claimed that the other had infringed upon their patents. The litigation was settled once Boston Scientific agreed to pay $716 million to Johnson & Johnson in September 2009 and an additional $1.73 billion in February 2010. It was announced in November 2014 that Johnson & Johnson would have another chance for payback after a multibillion dollar trial was set for November 20, 2014. A New York federal court judge would hear the case without a jury to decide whether Boston Scientific should be held liable for the contract breach.

Boston Scientific is one of several manufacturers of a medical device called transvaginal mesh, a type of surgical mesh used to treat pelvic organ prolapse. Experts concluded that the medical company had used cheap, counterfeit resin, which was both toxic and degraded when exposed to oxygen. When this was announced on 60 Minutes, Boston Scientific responded by saying the broadcast was "irresponsible and misleading," citing a 2017 Food and Drug Administration (FDA) report stating that although they found variability in the polypropylene resin, "these differences do not present new safety or effectiveness concerns." One woman, who sued in 2011, was awarded $100 million. Two operations had failed to remove all the parts of the mesh and she was still in pain. The company appealed the decision and had the amount reduced to $10M. In 2015, Boston Scientific announced it would pay $119 million to 2,970 lawsuit plaintiffs, who had been injured by the mesh. On March 23, 2021, the company agreed to pay $189 million to settle allegations that it had seriously misrepresented the risks related to the vaginal mesh. As of Jan. 27, 2021, around 54,000 lawsuits related to transvaginal meshes had been filed against Boston Scientific. In April 2019, the FDA ordered Boston Scientific and Coloplast to remove all of their vaginal mesh products from the United States market. In 2020, Johnson & Johnson was required to pay $344 million for failing to disclose the serious product risks of its transvaginal mesh product.

In 2005, Boston Scientific paid $74 million to settle allegations that it had continued to sell NIR stents (flexible stents) after learning that many of them were defective. Twenty six injuries and one death may have been caused by malfunctioning stents.

In 2011, Guidant, a subsidiary of Boston Scientific, was criminally convicted of a failure to report defibrillator safety problems to the FDA. The company was forced to pay more than $296 million in criminal fines and had to submit to the supervision of the U. S. Probation Office for three years. Even though Guidant knew the devices were defective, they continued to sell the defibrillators anyway. Guidant LLC had also advised its sales representatives to tell physicians that nothing was wrong with the defibrillators, and told the FDA that the proposed corrections were not being done to correct life threatening device flaws, but were rather to improve process throughout. Not until three deaths had occurred and ten months had passed did the company reveal the defects in 2005. The directives for these wrongdoings had been implemented prior to Boston Scientific’s acquisition of Guidant in 2006. In 2013, BSC and three of its subsidiaries – Guidant LLC, Guidant Sales LLC, and Cardiac Pacemakers, Inc. – agreed to pay $30 million to settle allegations that, according to the Justice Department, between 2002 and 2005, Guidant knowingly sold defective heart devices to health care facilities that in turn implanted the devices into Medicare patients.

In 2009, Boston Scientific agreed to pay $22 million to settle allegations that its subsidiary Guidant LLC had used kickback schemes to boost sales for its pacemakers (cardiac rhythm management or CRM devices) and defibrillators (implantable cardioverter defibrillators or ICD devices). Allegedly, Guidant paid doctors between $1,000 and $1,500 each to participate in one of its four post studies known as RaCE ($1,500), RaCE II ($1,000), RaCE III ($1,000), and MERITS ($1,000).

In April 2024, the FDA announced a recall of Boston Scientific's device, Obsidio Embolic, which is used to stop hemorrhaging and excessive bleeding. It has been found that when the device is paired with the aliquot technique, it can lead to bowel ischemia, which can mean longer hospitalization or death for patients.

On November 3, 1998, Boston Scientific restated its financial results for 1997, as well as its quarterly results for the first three quarters of 1998, due to the occurrence of business irregularities in the operations of its Japanese subsidiary.