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FDA Approves Intuitive Surgical's (ISRG) Latest SureForm Stapler
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Intuitive Surgical, Inc. (ISRG - Free Report) recently received the FDA’s clearance for its fully wristed, 8 mm SureForm 30 Curved-Tip Stapler and reloads (gray, white and blue) for use in general, thoracic, gynecologic, urologic and pediatric surgery. The latest stapler is expected to be launched in the United States in 2022, followed by other countries.
For investors’ note, the 8 mm SureForm 30 Curved-Tip Stapler integrates SmartFire technology, similar to the other SureForm staplers.
The latest regulatory approval is expected to significantly solidify Intuitive Surgical’s Instruments and Accessories business on a global scale.
Significance of the Nod
Intuitive Surgical’s latest type of the SureForm stapler was designed to aid surgeons to better visualize and reach patient anatomy. It is the first 8 mm robotic stapler with 120-degree articulation and SmartFire technology. As the stapler fits through the 8 mm da Vinci surgical system instrument cannula, the stapler allows surgeons to approach patient anatomy via various angles.
Per a thoracic surgeon based in Wisconsin, an 8 mm diameter stapler option (especially during complex procedures) will likely provide more options to the surgeons to confidently access the target anatomy.
Per management, the 8 mm SureForm 30 curved tip stapler is expected to provide better access and visibility during stapling procedures.
Industry Prospects
Per a report by Fortune Business Insights, the global surgical stapling devices market was valued at $2.16 billion in 2018 and is anticipated to reach $3.81 billion by 2026 at a CAGR of 7.4%. Factors like technological advancements and the growing preference for staples over sutures are expected to drive the market.
Given the market potential, the latest regulatory clearance seems to have been timed well.
Recent Developments
Of late, Intuitive Surgical has witnessed a few notable developments across its business.
This month, the company announced that the global number of robotic-assisted surgical procedures performed using da Vinci surgical systems has surpassed 10 million.
Intuitive Surgical, in November, reported robust third-quarter 2021 results, wherein it recorded strong segmental performances. The company’s revenue growth in the reported quarter reflected procedure increase and rise in system placements.
In October, the company announced the release of preliminary data from the Prospective, Multi-Center Evaluation of the Clinical Utility (PRECIsE) — a post-market, multi-center clinical trial of its Ion endoluminal system. Intuitive Surgical’s Ion Endoluminal System for Peripheral Nodule Lung Biopsy was used in the trial.
Price Performance
Shares of Intuitive Surgical have gained 27.6% in the past year compared with the industry’s 6.9% growth and the S&P 500's 27.2% rise.
Image Source: Zacks Investment Research
Zacks Rank & Key Picks
Currently, Intuitive Surgical carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the broader medical space are Laboratory Corporation of America Holdings (LH - Free Report) or LabCorp, Thermo Fisher Scientific Inc. (TMO - Free Report) and AMN Healthcare Services (AMN - Free Report) .
LabCorp, flaunting a Zacks Rank #1 (Strong Buy), has an estimated long-term growth rate of 10.6%. The company’s earnings surpassed estimates in the trailing four quarters, the average surprise being 25.73%. You can see the complete list of today’s Zacks #1 Rank stocks here.
LabCorp has gained 51.5% compared with the industry’s 12.1% rise over the past year.
Thermo Fisher has an estimated long-term growth rate of 14%. The company’s earnings surpassed estimates in the trailing four quarters, the average surprise being 9.02%. It currently carries a Zacks Rank #2 (Buy).
Thermo Fisher has gained 41% compared with the industry’s 6.9% rise over the past year.
AMN Healthcare has an estimated long-term growth rate of 16.2%. The company’s earnings surpassed estimates in the trailing four quarters, the average surprise being 19.51%. It currently sports a Zacks Rank #1.
AMN Healthcare has gained 67.3% against the industry’s 59% fall over the past year.
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FDA Approves Intuitive Surgical's (ISRG) Latest SureForm Stapler
Intuitive Surgical, Inc. (ISRG - Free Report) recently received the FDA’s clearance for its fully wristed, 8 mm SureForm 30 Curved-Tip Stapler and reloads (gray, white and blue) for use in general, thoracic, gynecologic, urologic and pediatric surgery. The latest stapler is expected to be launched in the United States in 2022, followed by other countries.
For investors’ note, the 8 mm SureForm 30 Curved-Tip Stapler integrates SmartFire technology, similar to the other SureForm staplers.
The latest regulatory approval is expected to significantly solidify Intuitive Surgical’s Instruments and Accessories business on a global scale.
Significance of the Nod
Intuitive Surgical’s latest type of the SureForm stapler was designed to aid surgeons to better visualize and reach patient anatomy. It is the first 8 mm robotic stapler with 120-degree articulation and SmartFire technology. As the stapler fits through the 8 mm da Vinci surgical system instrument cannula, the stapler allows surgeons to approach patient anatomy via various angles.
Per a thoracic surgeon based in Wisconsin, an 8 mm diameter stapler option (especially during complex procedures) will likely provide more options to the surgeons to confidently access the target anatomy.
Per management, the 8 mm SureForm 30 curved tip stapler is expected to provide better access and visibility during stapling procedures.
Industry Prospects
Per a report by Fortune Business Insights, the global surgical stapling devices market was valued at $2.16 billion in 2018 and is anticipated to reach $3.81 billion by 2026 at a CAGR of 7.4%. Factors like technological advancements and the growing preference for staples over sutures are expected to drive the market.
Given the market potential, the latest regulatory clearance seems to have been timed well.
Recent Developments
Of late, Intuitive Surgical has witnessed a few notable developments across its business.
This month, the company announced that the global number of robotic-assisted surgical procedures performed using da Vinci surgical systems has surpassed 10 million.
Intuitive Surgical, in November, reported robust third-quarter 2021 results, wherein it recorded strong segmental performances. The company’s revenue growth in the reported quarter reflected procedure increase and rise in system placements.
In October, the company announced the release of preliminary data from the Prospective, Multi-Center Evaluation of the Clinical Utility (PRECIsE) — a post-market, multi-center clinical trial of its Ion endoluminal system. Intuitive Surgical’s Ion Endoluminal System for Peripheral Nodule Lung Biopsy was used in the trial.
Price Performance
Shares of Intuitive Surgical have gained 27.6% in the past year compared with the industry’s 6.9% growth and the S&P 500's 27.2% rise.
Zacks Rank & Key Picks
Currently, Intuitive Surgical carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the broader medical space are Laboratory Corporation of America Holdings (LH - Free Report) or LabCorp, Thermo Fisher Scientific Inc. (TMO - Free Report) and AMN Healthcare Services (AMN - Free Report) .
LabCorp, flaunting a Zacks Rank #1 (Strong Buy), has an estimated long-term growth rate of 10.6%. The company’s earnings surpassed estimates in the trailing four quarters, the average surprise being 25.73%. You can see the complete list of today’s Zacks #1 Rank stocks here.
LabCorp has gained 51.5% compared with the industry’s 12.1% rise over the past year.
Thermo Fisher has an estimated long-term growth rate of 14%. The company’s earnings surpassed estimates in the trailing four quarters, the average surprise being 9.02%. It currently carries a Zacks Rank #2 (Buy).
Thermo Fisher has gained 41% compared with the industry’s 6.9% rise over the past year.
AMN Healthcare has an estimated long-term growth rate of 16.2%. The company’s earnings surpassed estimates in the trailing four quarters, the average surprise being 19.51%. It currently sports a Zacks Rank #1.
AMN Healthcare has gained 67.3% against the industry’s 59% fall over the past year.