We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Intuitive Surgical (ISRG) Gets FDA Nod for da Vinci's New Label
Read MoreHide Full Article
Intuitive Surgical (ISRG - Free Report) recently announced the FDA 510(k) clearance of a labeling revision for its da Vinci X and Xi specific to radical prostatectomy.
This clearance was granted based on real-world evidence (RWE) gathered between 2007 and 2014, which shows that the overall five to 10-year survival rate after radical prostatectomy with robotic assistance is similar to that of non-robotic radical prostatectomy.
Price Performance
In the past six months, ISRG shares have gained 34.7% compared with the industry’s rise of 15.4%. The S&P 500 has gained 16.5% in the same time frame.
Image Source: Zacks Investment Research
More on the Labeling Revision
To validate the authenticity of the real-world data utilized in the labeling amendment submission, Intuitive Surgical collaborated in a public-private partnership with the FDA, the healthcare analytics firm Aetion and the National Evaluation System for Health Technology (“NEST”), using its NEST Mark procedure.
This effort showed the value of working together to produce high-quality RWE to support FDA marketing applications. It may also pave the way for more thorough long-term survival assessments of other cancer procedures, which would further the field of regulatory science.
The labeling change applies specifically to the Precaution for Representative Uses statement for the da Vinci X and Xi systems. The previous precaution statement noted that the FDA did not review the evaluation of outcomes related to the cancer treatment.
The revised version states that the evaluation of outcomes related to cancer treatment (overall survival, disease-free survival, local recurrence) was not included in the demonstration of safety and effectiveness for the representative-specific procedures, with the exception of radical prostatectomy, which was evaluated for overall survival, or treatment of the patient's underlying disease or condition.
Intuitive Surgical provided data from a retrospective cohort study comparing overall survival after radical prostatectomy via robotic-assisted surgery compared to open surgery among patients with treatment-naive prostate cancer in the United States. The study used de-identified healthcare claims data from the Optum Clinformatics Data Mart. About 25,000 patients were included in the study evaluation, and the 2007-2014 period was selected to prevent confounding effects associated with the COVID-19 pandemic.
More on da Vinci Surgical Systems
The goal of the da Vinci surgical systems is to aid surgeons in doing minimally invasive surgery by providing them with enhanced vision, robotic and computer support, and high-definition 3D vision. The systems provide specialized equipment, such as a miniature surgical camera and wristed instruments (scalpels, scissors, and forceps), to facilitate accurate dissection and rebuilding from the inside out.
The da Vinci portfolio currently includes seven approved systems, which are the da Vinci standard surgical system (1999), the da Vinci S surgical system (2006), the da Vinci Si surgical system (2009), the fourth-generation surgical systems (da Vinci Xi [2014], da Vinci X [2017] and da Vinci SP [2018]) and the fifth-generation da Vinci 5 surgical system (2024).
In March 2024, ISRG obtained FDA clearance for da Vinci 5, its next-generation multi-port robotic system, for use in all surgical specialties and procedures indicated for da Vinci Xi, except for cardiac and pediatric indications as well as one contraindication related to the use of force feedback in hysterectomy and myomectomy procedures.
Apart from the United States, the company commercializes the da Vinci systems in Europe, China, Japan and South Korea. The company is currently seeking approval for the latest da Vinci 5 surgical system in Japan and South Korea. The company also has plans to expand into other international markets. The company expects to expand its presence internationally, which will be a key driver of da Vinci sales in upcoming years.
Per the first quarter of 2024 earnings call, the installed base of da Vinci systems grew approximately 14% year over year to 8,887 units. In the first quarter of 2024, procedures improved 14% in the United States and 20% outside of U.S. markets compared with the prior-year quarter. The sale of da Vinci systems in the rest of 2024 is likely to be driven by the launch of da Vinci 5 in the U.S. market and Da Vinci SP in Europe.
Industry Prospects
Per a report by MarketsandMarkets, the global surgical robots market size was valued at $8.5 billion in 2022 and is expected to reach $18.4 billion by 2027 at a growth rate of 16.6%.
The benefits of laparoscopic or minimally invasive surgery to patients and surgeons, including improved screening, increased precision, shorter hospital stays, and less pain and suffering, are driving up demand for and acceptance of this procedure, thereby leading to the expansion of the market.
Some better-ranked stocks in the broader medical space that have announced quarterly results are Align Technology, Inc. (ALGN - Free Report) , Ecolab (ECL - Free Report) and Boston Scientific Corporation (BSX - Free Report) .
Align Technology, currently carrying a Zacks Rank of 2 (Buy), reported first-quarter 2024 adjusted earnings per share (EPS) of $2.14, which beat the Zacks Consensus Estimate by 8.1%. Revenues of $997.4 million outpaced the consensus mark by 2.6%. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Align Technology has a long-term estimated growth rate of 6.9%. ALGN’s earnings surpassed estimates in three of the trailing four quarters and missed once, the average surprise being 5.9%.
Ecolab, carrying a Zacks Rank of 2 at present, has an estimated long-term growth rate of 13.3%. ECL’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 1.7%.
Ecolab’s shares have rallied 33.8% against the industry’s 9.3% decline in the past year.
Boston Scientific reported first-quarter 2024 adjusted EPS of 56 cents, which beat the Zacks Consensus Estimate by 9.8%. Revenues of $3.86 billion surpassed the Zacks Consensus Estimate by 4.9%. It currently carries a Zacks Rank #2.
Boston Scientific has a long-term estimated growth rate of 12.5%. BSX’s earnings surpassed estimates in the trailing four quarters, the average surprise being 7.5%.
Unique Zacks Analysis of Your Chosen Ticker
Pick one free report - opportunity may be withdrawn at any time
Image: Bigstock
Intuitive Surgical (ISRG) Gets FDA Nod for da Vinci's New Label
Intuitive Surgical (ISRG - Free Report) recently announced the FDA 510(k) clearance of a labeling revision for its da Vinci X and Xi specific to radical prostatectomy.
This clearance was granted based on real-world evidence (RWE) gathered between 2007 and 2014, which shows that the overall five to 10-year survival rate after radical prostatectomy with robotic assistance is similar to that of non-robotic radical prostatectomy.
Price Performance
In the past six months, ISRG shares have gained 34.7% compared with the industry’s rise of 15.4%. The S&P 500 has gained 16.5% in the same time frame.
Image Source: Zacks Investment Research
More on the Labeling Revision
To validate the authenticity of the real-world data utilized in the labeling amendment submission, Intuitive Surgical collaborated in a public-private partnership with the FDA, the healthcare analytics firm Aetion and the National Evaluation System for Health Technology (“NEST”), using its NEST Mark procedure.
This effort showed the value of working together to produce high-quality RWE to support FDA marketing applications. It may also pave the way for more thorough long-term survival assessments of other cancer procedures, which would further the field of regulatory science.
The labeling change applies specifically to the Precaution for Representative Uses statement for the da Vinci X and Xi systems. The previous precaution statement noted that the FDA did not review the evaluation of outcomes related to the cancer treatment.
The revised version states that the evaluation of outcomes related to cancer treatment (overall survival, disease-free survival, local recurrence) was not included in the demonstration of safety and effectiveness for the representative-specific procedures, with the exception of radical prostatectomy, which was evaluated for overall survival, or treatment of the patient's underlying disease or condition.
Intuitive Surgical provided data from a retrospective cohort study comparing overall survival after radical prostatectomy via robotic-assisted surgery compared to open surgery among patients with treatment-naive prostate cancer in the United States. The study used de-identified healthcare claims data from the Optum Clinformatics Data Mart. About 25,000 patients were included in the study evaluation, and the 2007-2014 period was selected to prevent confounding effects associated with the COVID-19 pandemic.
More on da Vinci Surgical Systems
The goal of the da Vinci surgical systems is to aid surgeons in doing minimally invasive surgery by providing them with enhanced vision, robotic and computer support, and high-definition 3D vision. The systems provide specialized equipment, such as a miniature surgical camera and wristed instruments (scalpels, scissors, and forceps), to facilitate accurate dissection and rebuilding from the inside out.
The da Vinci portfolio currently includes seven approved systems, which are the da Vinci standard surgical system (1999), the da Vinci S surgical system (2006), the da Vinci Si surgical system (2009), the fourth-generation surgical systems (da Vinci Xi [2014], da Vinci X [2017] and da Vinci SP [2018]) and the fifth-generation da Vinci 5 surgical system (2024).
In March 2024, ISRG obtained FDA clearance for da Vinci 5, its next-generation multi-port robotic system, for use in all surgical specialties and procedures indicated for da Vinci Xi, except for cardiac and pediatric indications as well as one contraindication related to the use of force feedback in hysterectomy and myomectomy procedures.
Apart from the United States, the company commercializes the da Vinci systems in Europe, China, Japan and South Korea. The company is currently seeking approval for the latest da Vinci 5 surgical system in Japan and South Korea. The company also has plans to expand into other international markets. The company expects to expand its presence internationally, which will be a key driver of da Vinci sales in upcoming years.
Per the first quarter of 2024 earnings call, the installed base of da Vinci systems grew approximately 14% year over year to 8,887 units. In the first quarter of 2024, procedures improved 14% in the United States and 20% outside of U.S. markets compared with the prior-year quarter. The sale of da Vinci systems in the rest of 2024 is likely to be driven by the launch of da Vinci 5 in the U.S. market and Da Vinci SP in Europe.
Industry Prospects
Per a report by MarketsandMarkets, the global surgical robots market size was valued at $8.5 billion in 2022 and is expected to reach $18.4 billion by 2027 at a growth rate of 16.6%.
The benefits of laparoscopic or minimally invasive surgery to patients and surgeons, including improved screening, increased precision, shorter hospital stays, and less pain and suffering, are driving up demand for and acceptance of this procedure, thereby leading to the expansion of the market.
Intuitive Surgical, Inc. Price
Intuitive Surgical, Inc. price | Intuitive Surgical, Inc. Quote
Zacks Rank & Stocks to Consider
ISRG carries a Zacks Rank #3 (Hold) at present.
Some better-ranked stocks in the broader medical space that have announced quarterly results are Align Technology, Inc. (ALGN - Free Report) , Ecolab (ECL - Free Report) and Boston Scientific Corporation (BSX - Free Report) .
Align Technology, currently carrying a Zacks Rank of 2 (Buy), reported first-quarter 2024 adjusted earnings per share (EPS) of $2.14, which beat the Zacks Consensus Estimate by 8.1%. Revenues of $997.4 million outpaced the consensus mark by 2.6%. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Align Technology has a long-term estimated growth rate of 6.9%. ALGN’s earnings surpassed estimates in three of the trailing four quarters and missed once, the average surprise being 5.9%.
Ecolab, carrying a Zacks Rank of 2 at present, has an estimated long-term growth rate of 13.3%. ECL’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 1.7%.
Ecolab’s shares have rallied 33.8% against the industry’s 9.3% decline in the past year.
Boston Scientific reported first-quarter 2024 adjusted EPS of 56 cents, which beat the Zacks Consensus Estimate by 9.8%. Revenues of $3.86 billion surpassed the Zacks Consensus Estimate by 4.9%. It currently carries a Zacks Rank #2.
Boston Scientific has a long-term estimated growth rate of 12.5%. BSX’s earnings surpassed estimates in the trailing four quarters, the average surprise being 7.5%.