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Boston Scientific's First Single-Use Duodenoscope Gets FDA Nod

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Boston Scientific Corporation BSX received the FDA approval for its EXALT Model D single-use duodenoscope, which is to be used in endoscopic retrograde cholangiopancreatography (ERCP) procedures.

Beside the approval, the FDA granted Breakthrough Device Designation to the duodenoscope to ensure timely access to the device by patients and healthcare providers. Notably, the EXALT Model D duodenoscope is the first and only FDA cleared single-use (disposable) duodenoscope currently available in the market.

Per the medical fraternity, apart from performing high-quality ERCP procedures, the latest version of the duodenoscope will have an added advantage of using a brand-new sterile device for each patient.

With the FDA clearance, the company aims to strengthen its endoscopy business on a global scale. Notably, endoscopy is a segment under the broader MedSurg arm of Boston Scientific.

 

 

Why is the Clearance Significant?

The EXALT Model D single-use duodenoscope is being touted as a pathbreaking device as it can be used as an alternative to reusable duodenoscopes, thus removing the need for duodenoscope reprocessing and repairs.

Notably, more than 1.5 million ERCPs are performed worldwide, using duodenoscopes, to diagnose, and treat various pancreatic and biliary conditions. However, there have been cases where infections have been transmitted to patients through contaminated devices despite adherence to established protocols of rigorous disinfection processes.

The FDA, in an effort to counter the problem, issued a recommendation to shift to duodenoscopes with disposable components or fully disposable devices. With the recent clearance, the EXALT Model D duodenoscope will provide the solution to the aforementioned concern.

Boston Scientific conducted a consecutive case series of the EXALT Model D duodenoscope. It concluded that expert endoscopists were able to complete ERCPs across a wide range of complexity using the single-use duodenoscope.

Industry Prospects

Per a report by Allied Market Research, the global endoscopy devices market size was estimated at $30,011.13 million in 2018, and is expected to reach a market capitalization of $45,390 million by 2026, witnessing a CAGR of 5.4% between 2019 and 2026. The key factors driving the market are the increasing prevalence of diseases requiring endoscopy devices and technological advancements in endoscopes that can be used for early detection of diseases.

With the given market potential, the clearance has been well- timed.

Recent Regulatory Approvals

Of late, Boston Scientific is witnessing a slew of regulatory approvals and product launch.

In September 2019, the company received the FDA clearance for its Premarket Approval (PMA) application to market the Eluvia Drug-Eluting Vascular Stent system. The stent system has been developed specifically for the treatment of peripheral artery disease (PAD).

Boston Scientific received the FDA nod in August 2019 for its ImageReady MRI labeling for the Vercise Gevia Deep Brain Stimulation (DBS) system, which will be used in a full-body magnetic resonance imaging (MRI) environment.

The company launched the WATCHMAN Left Atrial Appendage Closure Device in Japan, upon securing positive local reimbursement in the third quarter of 2019. In September 2019, it also announced receiving the CE Mark for the SYNERGY MEGATRON Bioabsorbable Polymer Stent, designed for use in large proximal vessels.

Price Performance

Shares of Boston Scientific have gained 32.4% in the past year compared with the industry’s 13.7% growth.

Zacks Rank & Key Picks

Currently, the company carries a Zacks Rank #3 (Hold).

Some better-ranked stocks from the broader medical space are Haemonetics Corporation HAE, National Vision Holdings, Inc EYE and ResMed Inc RMD.

Haemonetics currently has a Zacks Rank #2 (Buy) and a projected long-term earnings growth rate of 13.5%.

National Vision’s long-term earnings growth rate is estimated at 17.8%. The company currently carries a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

ResMed’s long-term earnings growth rate is estimated at 14%. It currently flaunts a Zacks Rank #1.

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