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BSX Gets FDA Nod on INGEVITY+ Pacing Lead in the LBBA: Stock to Gain?
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Boston Scientific Corporation (BSX - Free Report) recently received the Food and Drug Administration’s (FDA) approval to expand the indication for current-generation INGEVITY+ Pacing Leads. Expanded indication for INGEVITY+ Pacing Leads means thin wires will be placed inside the heart that will be connected to an implantable device. It can be used to include conduction system pacing (CSP) and sensing of the left bundle branch area (LBBA) when connected to a single or dual-chamber pacemaker.
The latest FDA approval enhances Boston Scientific’s commitment to developing safe and effective pacing technologies by providing physicians with LBBA-specific tools and educational resources.
BSX’s Likely Stock Trend Following the News
Following the announcement, shares of Boston Scientific lost 1.2% to $82.52 yesterday. However, the company continues to gain a high level of synergies from its continuous development within the cardiology space. Accordingly, we expect market sentiment toward BSX stock to eventually gain investors' optimism over this development.
Importance of BSX’s Expanded indication for INGEVITY+ Pacing Leads
Pacing of the LBBA is an alternative to traditional right ventricular pacing for the treatment of symptomatic bradycardia — a condition in which the heart beats too slowly. This pacing approach uses the heart's natural electrical system to place a lead in the LBBA of the heart's conduction system. This technique is expected to promote greater ventricular synchrony and reduce the long-term risk of heart failure associated with traditional right ventricular pacing.
Hence, the expanded indication for the INGEVITY+ Pacing Lead should enhance the implant experience for physicians and provide flexibility to determine the most appropriate pacing strategy based on individual patient characteristics.
Details of the FDA Approval
Clinical evidence submitted to the FDA to support the expanded indication includes data from approximately 400 patients from the INSIGHT-LBBA study. The study shows an analysis of the INGEVITY+ pacing leads that were previously implanted in the LBBA for anti-bradycardia pacing and were supplemented with bench testing and LATITUDE Programming System data.
Data demonstrated this lead to be safe and effective for LBBA pacing, allowing Boston Scientific to provide a new therapeutic option on a proven lead.
More on the News
The expanded indication followed the launch of the Boston Scientific CSP portfolio, including the OneLINK Splitter Cable, the INGEVITY+ Helix Locking Tool and site-selective pacing delivery catheters.
Image Source: Zacks Investment Research
Industry Prospects Favor Boston Scientific
Per a Verified Market Research report, the pacing lead market was valued at $5.68 billion in 2024 and is projected to reach $7.8 billion by 2031, at a compound annual growth rate of 4.43% during the period. Key factors driving market growth include the increasing prevalence of cardiovascular diseases, technological advancements and the growing preference for minimally invasive operations.
Recent Development by BSX
On Tuesday, the company closed its acquisition of Silk Road Medical, Inc. With this, Boston Scientific should be able to strengthen its vascular technology solutions by bringing the innovative TCAR platform to a greater number of physicians and their patients (through the company’s significant commercial reach).
BSX’s Price Performance
In the past year, shares of BSX have risen 55.7% compared with the industry’s 20.3% growth.
Estimates for TransMedics’ 2024 earnings per share (EPS) have moved up 2.5% to $1.23 in the past 30 days. Shares of the company have soared 156.5% in the past year compared with the industry’s 17.5% growth. TMDX’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 287.50%. In the last reported quarter, it delivered an earnings surprise of 66.67%.
Estimates for AxoGen’s 2024 loss per share have remained constant at 1 cent in the past 30 days. Shares of the company have surged 165.9% in the past year compared with the industry’s 17.6% growth. AXGN’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 96.5%. In the last reported quarter, it delivered an earnings surprise of 200%
Estimates for 2024 OrthoPediatrics’ loss per share have declined to 92 cents from 96 cents in the past 30 days. In the past year, shares of KIDS have lost 0.8% against the industry’s 18.1% growth. In the last reported quarter, KIDS delivered an earnings surprise of 25.81%. Its earnings surpassed estimates in each of the trailing four quarters, the average surprise being 26.81%.
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BSX Gets FDA Nod on INGEVITY+ Pacing Lead in the LBBA: Stock to Gain?
Boston Scientific Corporation (BSX - Free Report) recently received the Food and Drug Administration’s (FDA) approval to expand the indication for current-generation INGEVITY+ Pacing Leads. Expanded indication for INGEVITY+ Pacing Leads means thin wires will be placed inside the heart that will be connected to an implantable device. It can be used to include conduction system pacing (CSP) and sensing of the left bundle branch area (LBBA) when connected to a single or dual-chamber pacemaker.
The latest FDA approval enhances Boston Scientific’s commitment to developing safe and effective pacing technologies by providing physicians with LBBA-specific tools and educational resources.
BSX’s Likely Stock Trend Following the News
Following the announcement, shares of Boston Scientific lost 1.2% to $82.52 yesterday. However, the company continues to gain a high level of synergies from its continuous development within the cardiology space. Accordingly, we expect market sentiment toward BSX stock to eventually gain investors' optimism over this development.
Importance of BSX’s Expanded indication for INGEVITY+ Pacing Leads
Pacing of the LBBA is an alternative to traditional right ventricular pacing for the treatment of symptomatic bradycardia — a condition in which the heart beats too slowly. This pacing approach uses the heart's natural electrical system to place a lead in the LBBA of the heart's conduction system. This technique is expected to promote greater ventricular synchrony and reduce the long-term risk of heart failure associated with traditional right ventricular pacing.
Hence, the expanded indication for the INGEVITY+ Pacing Lead should enhance the implant experience for physicians and provide flexibility to determine the most appropriate pacing strategy based on individual patient characteristics.
Details of the FDA Approval
Clinical evidence submitted to the FDA to support the expanded indication includes data from approximately 400 patients from the INSIGHT-LBBA study. The study shows an analysis of the INGEVITY+ pacing leads that were previously implanted in the LBBA for anti-bradycardia pacing and were supplemented with bench testing and LATITUDE Programming System data.
Data demonstrated this lead to be safe and effective for LBBA pacing, allowing Boston Scientific to provide a new therapeutic option on a proven lead.
More on the News
The expanded indication followed the launch of the Boston Scientific CSP portfolio, including the OneLINK Splitter Cable, the INGEVITY+ Helix Locking Tool and site-selective pacing delivery catheters.
Image Source: Zacks Investment Research
Industry Prospects Favor Boston Scientific
Per a Verified Market Research report, the pacing lead market was valued at $5.68 billion in 2024 and is projected to reach $7.8 billion by 2031, at a compound annual growth rate of 4.43% during the period. Key factors driving market growth include the increasing prevalence of cardiovascular diseases, technological advancements and the growing preference for minimally invasive operations.
Recent Development by BSX
On Tuesday, the company closed its acquisition of Silk Road Medical, Inc. With this, Boston Scientific should be able to strengthen its vascular technology solutions by bringing the innovative TCAR platform to a greater number of physicians and their patients (through the company’s significant commercial reach).
BSX’s Price Performance
In the past year, shares of BSX have risen 55.7% compared with the industry’s 20.3% growth.
BSX’s Zacks Rank and Other Key Picks
BSX currently carries a Zacks Rank #2 (Buy).
Some other top-ranked stocks in the broader medical space are TransMedics Group (TMDX - Free Report) , AxoGen (AXGN - Free Report) and OrthoPediatrics (KIDS - Free Report) . While TransMedics sports a Zacks Rank #1 (Strong Buy) at present, AxoGen and OrthoPediatrics carry a Zacks Rank #2 each. You can see the complete list of today’s Zacks #1 Rank stocks here.
Estimates for TransMedics’ 2024 earnings per share (EPS) have moved up 2.5% to $1.23 in the past 30 days. Shares of the company have soared 156.5% in the past year compared with the industry’s 17.5% growth. TMDX’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 287.50%. In the last reported quarter, it delivered an earnings surprise of 66.67%.
Estimates for AxoGen’s 2024 loss per share have remained constant at 1 cent in the past 30 days. Shares of the company have surged 165.9% in the past year compared with the industry’s 17.6% growth. AXGN’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 96.5%. In the last reported quarter, it delivered an earnings surprise of 200%
Estimates for 2024 OrthoPediatrics’ loss per share have declined to 92 cents from 96 cents in the past 30 days. In the past year, shares of KIDS have lost 0.8% against the industry’s 18.1% growth. In the last reported quarter, KIDS delivered an earnings surprise of 25.81%. Its earnings surpassed estimates in each of the trailing four quarters, the average surprise being 26.81%.