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Boston Scientific (BSX) Grows IC Business With New FDA Nod
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Boston Scientific Corporation (BSX - Free Report) achieved a milestone with the recent FDA approval for its AGENT Drug-Coated Balloon (DCB). This marks the first drug-coated coronary balloon available in the United States.
This approval signals a key advancement in the treatment landscape for coronary in-stent restenosis (ISR), a challenging condition characterized by the narrowing of stented vessels due to plaque or scar tissue formation. With this, Boston Scientific is expected to broaden its Interventional Cardiology (IC) product line.
Addressing an Unmet Need
ISR constitutes a notable portion of percutaneous coronary interventions in the United States that comprises approximately 10% of cases. Traditionally, treating ISR has been complex, often necessitating additional stenting layers or radiation therapy. The AGENT DCB offers a dedicated solution, serving as an alternative to conventional therapies by delivering a therapeutic dose of paclitaxel directly to the vessel wall.
Clinical Superiority
The FDA’s approval for the AGENT DCB is supported by favorable data from the multicenter, prospective, randomized controlled AGENT IDE trial, which demonstrated the device's efficacy and safety profile. The trial showcased statistically superior outcomes compared to uncoated balloon angioplasty, with significant reductions in target lesion failure, clotting within the stent and risk of heart attack at the target vessel.
Image Source: Zacks Investment Research
Promising Expansion in Interventional Cardiology
With more than 100,000 patients treated globally and positive trial results, the AGENT DCB represents a promising avenue for Boston Scientific to expand its IC business.
The FDA approval paves the way for Boston Scientific to introduce the AGENT DCB to physicians across the United States in the coming months. This device is already available in Europe, parts of Asia Pacific and Latin America for the treatment of patients with ISR and previously untreated small vessel coronary disease.
Market Prospects
Going by a Research and Markets report, the global coronary artery disease treatment devices market is poised for robust growth, driven by technological advancements and strategic acquisitions. This market is expected to reach $38.27 billion in 2027, at a CAGR of 9.8%. Technological advancements are key trends gaining traction in the coronary artery disease market.
Share Price Performance
Over the past year, shares of BSX have surged 40.6% compared with the industry’s 5.8% growth.
Zacks Rank and Key Picks
Boston Scientific currently carries a Zacks Rank #3 (Hold).
Estimates for DaVita’s 2024 earnings per share have advanced from $8.46 to $8.97 in the past 30 days. Shares of the company have risen 56.7% in the past year compared with the industry’s growth of 18.1%.
DVA’s earnings surpassed estimates in each of the trailing four quarters, delivering an average surprise of 35.6%. In the last reported quarter, it delivered an average earnings surprise of 22.2%.
Cardinal Health’sshares have risen 49.9% in the past year. Earnings estimates for CAH have increased from $6.91 to $7.28 in fiscal 2024 and from $7.76 to $8.03 in fiscal 2025 in the past 30 days.
CAH’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 15.6%. In the last reported quarter, it posted an earnings surprise of 16.7%.
Estimates for Insulet’s 2024 earnings per share have increased from $2.54 to $3.03 in the past 30 days. Shares of the company have lost 42% in the past year against the industry’s growth of 11.7%.
PODD’s earnings surpassed estimates in each of the trailing four quarters, delivering an average surprise of100.1%. In the last reported quarter, it delivered an earnings surprise of 108.9%.
Disclaimer: This article has been written with the assistance of Generative AI. However, the author has reviewed, revised, supplemented, and rewritten parts of this content to ensure its originality and the precision of the incorporated information.
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Boston Scientific (BSX) Grows IC Business With New FDA Nod
Boston Scientific Corporation (BSX - Free Report) achieved a milestone with the recent FDA approval for its AGENT Drug-Coated Balloon (DCB). This marks the first drug-coated coronary balloon available in the United States.
This approval signals a key advancement in the treatment landscape for coronary in-stent restenosis (ISR), a challenging condition characterized by the narrowing of stented vessels due to plaque or scar tissue formation. With this, Boston Scientific is expected to broaden its Interventional Cardiology (IC) product line.
Addressing an Unmet Need
ISR constitutes a notable portion of percutaneous coronary interventions in the United States that comprises approximately 10% of cases. Traditionally, treating ISR has been complex, often necessitating additional stenting layers or radiation therapy. The AGENT DCB offers a dedicated solution, serving as an alternative to conventional therapies by delivering a therapeutic dose of paclitaxel directly to the vessel wall.
Clinical Superiority
The FDA’s approval for the AGENT DCB is supported by favorable data from the multicenter, prospective, randomized controlled AGENT IDE trial, which demonstrated the device's efficacy and safety profile. The trial showcased statistically superior outcomes compared to uncoated balloon angioplasty, with significant reductions in target lesion failure, clotting within the stent and risk of heart attack at the target vessel.
Image Source: Zacks Investment Research
Promising Expansion in Interventional Cardiology
With more than 100,000 patients treated globally and positive trial results, the AGENT DCB represents a promising avenue for Boston Scientific to expand its IC business.
The FDA approval paves the way for Boston Scientific to introduce the AGENT DCB to physicians across the United States in the coming months. This device is already available in Europe, parts of Asia Pacific and Latin America for the treatment of patients with ISR and previously untreated small vessel coronary disease.
Market Prospects
Going by a Research and Markets report, the global coronary artery disease treatment devices market is poised for robust growth, driven by technological advancements and strategic acquisitions. This market is expected to reach $38.27 billion in 2027, at a CAGR of 9.8%. Technological advancements are key trends gaining traction in the coronary artery disease market.
Share Price Performance
Over the past year, shares of BSX have surged 40.6% compared with the industry’s 5.8% growth.
Zacks Rank and Key Picks
Boston Scientific currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the broader medical space are DaVita (DVA - Free Report) , Cardinal Health (CAH - Free Report) and Insulet (PODD - Free Report) . DaVita presently sports a Zacks Rank #1 (Strong Buy), while Cardinal Health and Insulet carry a Zacks Rank #2 (Buy) each. You can see the complete list of today’s Zacks #1 Rank stocks here.
Estimates for DaVita’s 2024 earnings per share have advanced from $8.46 to $8.97 in the past 30 days. Shares of the company have risen 56.7% in the past year compared with the industry’s growth of 18.1%.
DVA’s earnings surpassed estimates in each of the trailing four quarters, delivering an average surprise of 35.6%. In the last reported quarter, it delivered an average earnings surprise of 22.2%.
Cardinal Health’sshares have risen 49.9% in the past year. Earnings estimates for CAH have increased from $6.91 to $7.28 in fiscal 2024 and from $7.76 to $8.03 in fiscal 2025 in the past 30 days.
CAH’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 15.6%. In the last reported quarter, it posted an earnings surprise of 16.7%.
Estimates for Insulet’s 2024 earnings per share have increased from $2.54 to $3.03 in the past 30 days. Shares of the company have lost 42% in the past year against the industry’s growth of 11.7%.
PODD’s earnings surpassed estimates in each of the trailing four quarters, delivering an average surprise of100.1%. In the last reported quarter, it delivered an earnings surprise of 108.9%.
Disclaimer: This article has been written with the assistance of Generative AI. However, the author has reviewed, revised, supplemented, and rewritten parts of this content to ensure its originality and the precision of the incorporated information.