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Guidant
Guidant
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Guidant Corporation, part of Boston Scientific and Abbott Labs, designs and manufactures artificial cardiac pacemakers, implantable cardioverter-defibrillators, stents, and other cardiovascular medical products. Their company headquarters is located in Indianapolis, Indiana. Their main competitors are Medtronic, St. Jude Medical, and Johnson and Johnson.

Key Information

History

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In February 1972, Cardiac Pacemakers, Inc. (CPI) of St. Paul, Minnesota was formed. CPI was a highly successful start up venture, increasing sales from zero in 1972 to over $47 million and highly profitable when it was acquired by Eli Lilly in 1978 for $127 million.[1] In 1977 Eli Lilly & Co. buys IVAC of San Diego (a manufacturer of medical pumps and other hospital equipment) for $60.5 million.[2] In 1980, Eli Lilly & Co. acquires Physio-Control of Redmond, WA. and Advanced Cardiovascular Systems of Santa Clara, CA [1984] (balloon dilatation catheters and guidewires) along with Devices for Vascular Intervention(DVI) of Redwood City, CA [1988] (athetectomy catheter). These companies formed the core product/therapy areas of the Medical Devices Division of Eli Lilly and Company.

In 1994, Lilly had a change in senior management and Randy Tobias, the new president & CEO, decided that Lilly would focus on its pharma and other related businesses. The Medical Devices Division was spun off and went public in late 1994 under the name of Guidant Corporation (NYSE and PCX: GDT). The new company focused on cardiac rhythm management (pacemakers and implantable defibrillators) and cardiac and vascular intervention products via coronary and peripheral stents, guidewires and balloon dilatation catheters. Less invasive heart surgery was another small business unit of Guidant.

In February 1999 the business acquired Sulzer Medicas electrophysiology business for $810 million cash[3] and in November of the same year, acquired CardioThoracic Systems, Inc.[4]

In July 2002 the company acquired Cook Group Incorporated,[5] and months later in December, Guidant acquired Cardiac Intelligence Corporation.[6]

In April 2003 the business acquired SyneCor, LLC, developer of a fully bioabsorbable vascular stent.[7] Months later, in June 2003 Guidant acquired X Technologies, Inc. for $60 million.[8]

In January 2004, the company acquired AFx inc., a pioneer in the field of microwave surgical cardiac ablation.[9]

Acquisition offer by Johnson & Johnson

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Johnson & Johnson announced that it was acquiring Guidant on December 15, 2004, for $76 a share, at a cost of $25.4 billion. The deal was approved by Guidant stockholders on April 27, 2005. On May 25, Guidant reported 26 cases of implantable defibrillator failure, including one death. The same day, the New York Times published an article accusing Guidant of waiting years before notifying physicians about the problems. On June 17, Guidant issued a safety advisory on seven models of defibrillator, followed a week later by advising doctors to discontinue use of four models. The scope of the problems steadily increased, and on July 18, 2005, Guidant issued a warning for nine different models of pacemakers from 1997 to 2000. The next day, Johnson & Johnson warned that the acquisition may be delayed due to these issues. On September 22, Guidant issued safety advisories and recalls for 170,000 of their pacemakers, 56% of their total pacemakers. On October 18, Johnson & Johnson gave an announcement that they were exploring alternatives to the acquisition, followed by a November 2 warning that they might pull out of the deal due to the regulatory issues and legal liabilities. On November 7, 2005, Guidant sued Johnson & Johnson to force them to complete the deal. On November 15, the two companies announced a renegotiated purchase price of $63 a share, or $21.5 billion, a 15% price reduction.

Acquisition offer by Boston Scientific

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On December 5, 2005, Boston Scientific made a surprise unsolicited $24.6 billion bid to acquire Guidant, offering $72 per share of Guidant, $36 in cash and a fixed number of Boston Scientific shares valued at $36 a share. Guidant's stock price rose 10% on the news. The offer was not actually finalized until after due diligence had been completed on January 8, 2006.

Counter-offers

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On January 11, 2006, Johnson & Johnson presented a counteroffer of $23.2 billion, still less than their original 2004 bid, which the Guidant board accepted. The next day, Boston Scientific increased their bid to $25 billion, followed the next day by Johnson & Johnson increasing their bid to $24.2 billion. It was not until January 17 that Boston Scientific produced a new offer of $27.2 billion ($80 per share), with the help of Abbott Laboratories. Abbott agreed to purchase $1.4 billion of Boston Scientific stock and pay $4.1 billion for Guidant's vascular intervention business upon completion of the merger. Without Abbott's financial assistance, it would have been unlikely that Boston Scientific could have produced the counteroffer.

On January 25, 2006, after Johnson & Johnson refused to raise their bid higher than $24.2 billion, Guidant declared Boston Scientific's offer "clearly superior" and accepted their bid. Guidant paid a $705 million termination fee to Johnson & Johnson.

On April 21, 2006, the deal with Boston Scientific was complete. This deal included Abbott Labs buying the vascular intervention business of Guidant for approximately $4.5 billion. Fortune magazine characterized the deal as the second worst deal ever, stating that the company paid too much for Guidant.[10] On July 27, 2006, Boston Scientific posted a loss of $4.26 billion for the quarter.[11]

Locations

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References

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from Grokipedia
Guidant Corporation was an American manufacturer headquartered in , specializing in cardiovascular and vascular products such as implantable cardioverter-defibrillators (ICDs), pacemakers, coronary stents, guidewires, and dilatation catheters. Founded in 1994 as a spin-off from , Guidant quickly expanded through innovation and acquisitions, introducing numerous products in the 1990s and achieving $931 million in sales by 1995. The company invested heavily in research and development, partnering with smaller firms and acquiring entities like EndoVascular Technologies in 1997 for $170 million, which bolstered its portfolio in endovascular solutions. By 2002, Guidant employed over 11,000 people and reported $3.23 billion in annual sales, trading on the under the ticker GDT. In the mid-2000s, Guidant encountered significant setbacks due to manufacturing defects in its ICDs and pacemakers, leading to widespread recalls starting in that affected hundreds of thousands of devices and drew regulatory scrutiny from the FDA. These issues derailed an initial $25.4 billion acquisition agreement with announced in December 2004, prompting lawsuits and a termination fee. ultimately acquired Guidant on April 21, 2006, in a $27 billion deal, integrating its cardiac rhythm management business while divesting the vascular intervention unit to for $6.4 billion to address antitrust concerns. The acquisition created a global leader in medical technologies but was followed by further recalls and legal resolutions, including a $30 million settlement in 2013 for off-label promotion of Guidant's former devices.

Founding and Early Development

Spin-off from Eli Lilly

In the early 1990s, and Company's Medical Devices and Diagnostics Division operated amid a transforming healthcare sector, where escalating costs, initiatives, and regulatory changes pressured pharmaceutical firms to concentrate resources on core and . Under new leadership, Chairman initiated a strategic restructuring to divest non-pharmaceutical assets, enabling the company to sharpen its focus on innovative therapies like Prozac and emerging biologics. This decision culminated in plans announced in January 1994 to separate the medical device and diagnostics businesses from Lilly's primary operations. Guidant Corporation was formally incorporated in on September 9, 1994, as the for five select businesses from Eli Lilly's Medical Devices and Diagnostics Division. The spin-off aimed to unlock value in these specialized units by granting them operational independence, with Lilly retaining initial ownership before a phased divestiture. The transferred assets centered on pioneering cardiovascular technologies, including Advanced Cardiovascular Systems Inc. for balloon angioplasty catheters and stents, Cardiac Pacemakers Inc. for implantable pacemakers, and Telectronics Pacing Systems Inc. for advanced pacing devices, alongside Devices for Vascular Intervention and Guidant itself as an integrating entity. These units collectively generated approximately $800 million in 1993 sales and employed over 4,500 people, positioning Guidant as a leader in from inception. Ronald W. Dollens, who had served as president of Eli Lilly's Medical Devices and Diagnostics Division since 1988, was appointed Guidant's inaugural president and to guide the new entity's strategic direction.

Initial Product Focus and IPO

Following its spin-off from in 1994, Guidant Corporation went public on December 14, 1994, listing on the (NYSE) and Pacific Coast Exchange (PCX) under the GDT. The raised approximately $200 million in capital, which was earmarked for , manufacturing expansion, and international market growth to support the company's emerging position in the medical device sector. Shares closed at $14.625 on the first day of trading, with volume exceeding 2.6 million shares, reflecting strong investor interest in Guidant's specialized portfolio of cardiovascular technologies. Guidant's initial product focus centered on cardiovascular devices, particularly implantable pacemakers and related diagnostic tools, which formed the core of its revenue streams in the mid-1990s. These products addressed critical needs in cardiac rhythm management, enabling less invasive treatments for arrhythmias and . By , the company reported net sales of $931 million, a significant increase from $862 million in 1994, driven by innovations such as advanced pacemaker leads and monitoring systems that improved patient outcomes and device reliability. In the mid-1990s, Guidant achieved notable gains in implantable cardiac devices, solidifying its status as a leading player in the sector alongside competitors like . This growth was fueled by the introduction of 25 new products in 1995 alone, capturing a substantial portion of the expanding global market for pacemakers and defibrillators, estimated at over $1 billion by the decade's end. Under the leadership of President and CEO Ronald W. Dollens, who assumed the role at the time of the spin-off, Guidant pursued a strategic vision emphasizing innovation in minimally invasive therapies, including the development of implantable cardioverter-defibrillators (ICDs) that revolutionized sudden cardiac death prevention and delivered breakthrough technologies to clinicians worldwide.

Products and Divisions

Cardiac Rhythm Management

The Cardiac Rhythm Management (CRM) division of Guidant specialized in the development, manufacturing, and distribution of implantable devices designed to regulate abnormal heart rhythms and support management. This included pacemakers for treating , implantable cardioverter-defibrillators (ICDs) for detecting and terminating life-threatening ventricular arrhythmias through shocks or pacing, and (CRT) devices that coordinated ventricular contractions to improve cardiac efficiency in patients with systolic dysfunction. These products addressed key clinical needs in , providing both symptom relief and life-saving interventions for conditions like , , and congestive . Key innovations in Guidant's CRM portfolio included the Contak TR, a biventricular pacemaker approved for patients with moderate to severe (New York Heart Association Class ) and prolonged QRS duration, which delivered synchronized pacing to both ventricles via leads in the right atrium, right ventricle, and to reduce dyssynchrony and enhance . Similarly, the Renewal ICD series, such as the Contak Renewal, integrated CRT with capabilities, featuring programmable antitachycardia pacing algorithms to interrupt slower ventricular tachyarrhythmias and high-energy shocks for fibrillation, thereby addressing both arrhythmic risks and symptoms in a single implantable system. These devices incorporated advanced sensing and therapy delivery mechanisms, such as adaptive rate response and morphology-based discrimination to minimize inappropriate therapies. A significant technological advancement came from Guidant's 2002 acquisition of Cardiac Intelligence Corporation for $19.3 million, which introduced remote monitoring capabilities through the Cardiac Intelligence system. This wireless platform allowed for the automatic transmission of diagnostic data from implanted pacemakers and ICDs to clinicians via telephone lines, enabling early detection of arrhythmias, battery status, and lead integrity issues without requiring in-office visits, thus enhancing patient outcomes in the Advanced Patient Management program. The CRM division later encountered product recalls in 2005-2006 that impacted device implantation rates, though these were addressed through corrective actions. Guidant's CRM segment established the company as a market leader in devices during the early , with products like ICDs and CRT systems driving substantial revenue growth; for instance, CRM accounted for approximately 45% of total revenue (about $825 million) in 1998 and remained a core contributor as overall sales reached $3.24 billion by 2002, reflecting strong demand for and therapies.

Vascular Intervention

The Vascular Intervention (VI) division of Guidant specialized in developing and manufacturing medical devices for treating arterial diseases through minimally invasive procedures, primarily focusing on coronary stents, balloon dilatation catheters, and endovascular solutions to address blockages and aneurysms in the cardiovascular system. These products enabled physicians to perform interventions without open-heart surgery, improving patient outcomes by restoring blood flow in clogged arteries and reinforcing weakened vessel walls. Key products in the VI portfolio included the Multi-Link stent system, a tubular stainless steel device designed as a mesh-like scaffold to prop open narrowed after . Approved for use in in 1995 and in the United States in 1997 by the FDA, the Multi-Link quickly gained market traction, allowing Guidant to challenge Johnson & Johnson's dominant position and capture a substantial share of the market. Another significant offering was the Ancure endograft, an endovascular device for treating abdominal aortic aneurysms (AAA) by deploying a fabric tube via to exclude the aneurysm from circulation and prevent rupture, available in tube and bifurcated configurations with an attachment system featuring V-shaped hooks. However, the Ancure endograft was discontinued in 2003 following safety concerns, including deployment failures, and related legal settlements. Balloon dilatation s complemented these by inflating at the site of arterial blockages to compress plaque and widen vessels, often used in conjunction with stents for optimal results. Guidant advanced the field through innovations in drug-eluting stents, which incorporated antiproliferative agents released gradually from the device surface to inhibit cell growth and significantly reduce in-stent restenosis rates—the re-narrowing of treated arteries due to tissue proliferation. Guidant contributed to these advancements, with its drug-eluting stents, through industry-wide clinical evaluations in the mid-2000s, demonstrating potential to lower restenosis from historical rates of around 20-30% with bare-metal stents to under 10%. The VI division played a pivotal role in Guidant's financial performance, with coronary stents alone accounting for approximately 50% of the U.S. market's $1.3 billion value by and contributing substantially to the company's overall sales of $3.24 billion that year, alongside the Cardiac Rhythm Management segment. This revenue stream underscored the division's importance, as vascular products represented a core growth driver through the early . As part of the 2006 acquisition process, Guidant's VI business was divested to .

Growth and Challenges

Key Acquisitions and Expansions

Guidant pursued strategic growth through targeted acquisitions and market expansions in the late 1990s and early 2000s, focusing on enhancing its cardiovascular portfolio and capabilities. In July 2002, the company announced an agreement to acquire Incorporated, a developer of vascular access products and endovascular devices, in a stock-for-stock transaction valued at up to $3 billion; however, the deal was terminated in January 2003 following disappointing results for a joint project, resulting in a $60.6 million charge to Guidant. A key completed acquisition was the purchase of Cardiac Intelligence Corporation in December 2002 for $19.3 million, which bolstered Guidant's remote monitoring technologies by integrating remote patient monitoring systems for transmitting patient data from implantable devices to healthcare providers, improving post-implant follow-up efficiency. This move aligned with Guidant's emphasis on advanced patient management systems, such as the LATITUDE platform, to support its cardiac rhythm management division. Beyond acquisitions, Guidant expanded into minimally invasive tools, notably through its division, which introduced the VasoView Endoscopic Vessel Harvesting System for less traumatic coronary artery grafting procedures, reducing incision size and recovery time compared to traditional open . The company also grew internationally, establishing direct operations in via Guidant Japan K.K. and expanding sales in and , where international revenues reached $1,177.8 million in , representing about 32% of total sales and driven by demand for stents and defibrillators in markets like (20% of sales) and (9%). These initiatives contributed to robust financial growth, with net sales rising from $931 million in 1995 to $3,765.6 million in , reflecting a of approximately 15% fueled by product innovation and global . By , Guidant had launched facilities like the Institute for Therapy Advancement in to train physicians on minimally invasive techniques, further solidifying its presence in high-growth regions.

2005-2006 Product Recalls

In June 2005, Guidant initiated a voluntary of approximately 29,000 implantable cardioverter defibrillators (ICDs), including models such as the Ventak Prizm 2 DR and Contak Renewal, due to defects that posed risks of lead fractures and battery short-circuiting, potentially rendering the devices unable to deliver life-saving shocks. These issues were linked to at least two deaths and more than 45 confirmed device failures, prompting Guidant to notify physicians and offer free replacements while advising against immediate explantation in most cases. The U.S. (FDA) classified this action as a Class I , the agency's most serious category, indicating a reasonable probability of serious adverse health consequences or death. The crisis escalated with additional actions throughout 2005 and into early 2006, as Guidant issued safety advisories for about 88,000 ICDs across various models due to similar flaws, including potential rapid battery depletion and lead insulation issues. Concurrently, the company recalled or warned on over 200,000 pacemakers, primarily affecting and models, where defects in sealing components and output circuits could lead to sudden loss of pacing function; these advisories covered nearly 170,000 units in September 2005 alone, following an earlier July warning for 28,000 older devices. While no deaths were directly attributed to the pacemaker issues at the time, they resulted in at least nine hospitalizations. The FDA responded aggressively, issuing a warning letter to Guidant in December 2005 after inspections revealed unresolved problems and delayed reporting of defects dating back to 2003, including failures in the Renewal models that the company had known about but not fully disclosed. Federal investigations ensued, highlighting Guidant's pattern of withholding data from regulators and physicians. This led to multiple class-action lawsuits filed in 2005 and 2006, in which plaintiffs alleged that Guidant had awareness of the defects as early as 2003 yet continued sales and implants without adequate warnings, exposing patients to unnecessary risks. The recalls triggered a sharp decline in Guidant's stock price, dropping from around $82 per share in early June to approximately $60 by , amid investor concerns over liability and future sales. Guidant recorded a $113 million pretax charge in the second quarter of for recall-related expenses, with total estimated costs for device replacements, refunds, and emerging legal settlements projected to exceed $500 million by early . These events also strained Guidant's ongoing acquisition talks, prompting bidders to reassess terms due to the heightened regulatory and financial risks.

Acquisition Process

Johnson & Johnson Agreement

On December 16, 2004, announced an agreement to acquire Guidant Corporation for approximately $25.4 billion in a cash-and-stock transaction, valuing Guidant at $76 per share. Under the terms, Guidant shareholders would receive $30.40 in cash and $45.60 in common stock for each share, subject to a stock collar mechanism to mitigate fluctuations in J&J's share price. The deal represented one of the largest acquisitions in the medical device industry at the time and was structured as a reverse triangular merger. The strategic rationale for the acquisition centered on Johnson & Johnson's desire to strengthen its cardiovascular device portfolio by integrating Guidant's leadership in cardiac rhythm management (CRM) devices, such as pacemakers and implantable defibrillators, and vascular intervention (VI) products, including stents and angioplasty catheters. Guidant's innovative technologies complemented J&J's existing medical device offerings, aiming to accelerate the development and global delivery of advanced therapies for heart conditions. Executives described the combination as a merger of equals that would leverage Guidant's entrepreneurial culture with J&J's extensive resources and distribution network to benefit patients worldwide. Guidant shareholders overwhelmingly approved the agreement on April 27, 2005, with more than 98% of votes in favor, reflecting strong pre-recall optimism about the deal's potential. The transaction awaited regulatory clearances from the U.S. and , with both companies anticipating closure by the end of 2005, pending standard closing conditions. However, product recalls announced later in 2005 prompted renegotiations of the original terms.

Boston Scientific Bid and Counteroffers

In December 2005, amid product recalls that prompted to renegotiate its acquisition agreement downward to approximately $63 per share, launched an unsolicited bid to acquire Guidant for $72 per share in cash and stock, valuing the company at about $25 billion. This offer, which represented a premium over Guidant's then-current share price, initiated a competitive war and highlighted the impact of the recalls on Guidant's valuation. Negotiations intensified in January 2006, with countering by raising its offer to $71 per share. responded by revising its proposal to $80 per share, valued at $27 billion, incorporating an expanded collar mechanism to provide Guidant shareholders with greater protection against fluctuations in 's stock price—specifically, adjusting the exchange ratio if shares traded between $22.62 and $28.86. Guidant's board determined this revised bid to be superior and terminated the merger agreement with on January 25, 2006, entering into a definitive agreement with the same day. did not pursue further counteroffers, citing ongoing antitrust reviews and the higher competing bid as factors in allowing the termination. The bidding process faced additional scrutiny from antitrust authorities, but the focus remained on the financial terms and . On March 31, 2006, Guidant shareholders overwhelmingly approved the merger with , with more than 98% of shares represented voting in favor, paving the way for the deal's progression despite lingering concerns from the recalls.

Operations and Legacy

Headquarters and Facilities

Guidant's corporate headquarters was established at 111 Monument Circle, 29th Floor, in , , following its 1994 spin-off from , serving as the central administrative hub for the newly independent medical device firm. This downtown location housed executive offices and oversaw key corporate functions, including sales and marketing operations, as well as coordination of activities across the company's global sites. The headquarters facilitated strategic decision-making and administrative support, reflecting Guidant's roots in as a hub for innovation in cardiovascular therapies. To support its expanding operations, Guidant developed manufacturing facilities in Puerto Rico, leveraging the region's incentives for medical device production. Key sites included a plant in Dorado for assembly and distribution of cardiovascular products, and another in Arecibo focused on specialized manufacturing processes. In Europe, Guidant established a significant facility in Clonmel, Ireland, beginning manufacturing operations in 1999 to produce coronary stents and other cardiovascular devices, thereby enhancing supply chain efficiency and serving as a base for regional distribution across Western Europe. Throughout the 1990s and 2000s, Guidant's operations grew substantially to meet rising demand, with expansions in and staffing to accommodate an increasing employee base that contributed to the company's overall workforce expansion to over 11,000 globally by the mid-2000s. These developments underscored 's role as a vital center for Guidant's administrative and operational growth. Following the 2006 acquisition by , the former headquarters transitioned into a regional sales office.

Post-Acquisition Integration

The merger between and Guidant Corporation was completed on April 21, 2006, after the approved the transaction contingent on required divestitures to mitigate antitrust risks in the cardiovascular device market. As a key element of these divestitures, Guidant sold its vascular intervention and endovascular businesses to for $4.1 billion in cash, enabling the deal's finalization and allowing to focus on Guidant's cardiac rhythm management (CRM) portfolio. This closure marked the end of Guidant as an independent entity, with its operations dissolving into 's structure. Post-acquisition, Guidant's CRM assets, including implantable defibrillators and pacemakers, were absorbed into a newly formed CRM Group within , enhancing the company's capabilities in cardiac therapy technologies. Integration efforts, however, faced challenges from prior product issues, culminating in a 2007 recall of approximately 73,000 Guidant-manufactured implantable cardiac defibrillators and defibrillators due to a defect that could lead to device failure. Despite these hurdles, the merger streamlined operations by consolidating research, manufacturing, and sales functions under 's umbrella. Boston Scientific phased out the Guidant brand in the years following the acquisition, transitioning all products to its own labeling to unify market presence and eliminate legacy associations with recalls. Guidant's former headquarters in was repurposed as a regional office for , symbolizing the operational wind-down. The acquisition's long-term legacy solidified 's leadership in cardiovascular devices, creating a global powerhouse in CRM and related therapies through combined innovation and market share gains. Legal repercussions from Guidant's pre-acquisition device defects persisted into the 2010s, with reaching settlements such as a $30 million civil agreement with the U.S. Department of Justice in to resolve allegations of knowingly selling faulty implantable defibrillators.

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