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Medtronic's (MDT) Emprint Ablation System Study Data Positive

Medtronic's (MDT) Emprint Ablation Catheter Kit received Breakthrough Device Designation status from the FDA in April 2021 and is currently in develop...

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This story originally appeared on Zacks

Medtronic plc MDT recently published new clinical data from the NAVABLATE study released in the late-breaking presentation at the virtual European Respiratory Society International Congress 2021. The study highlights the feasibility of bronchoscopic microwave ablation for certain patients with malignant lung nodules.

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The outcomes from the NAVABLATE study explore the probable benefit of a more customized treatment for patients and provide a new alternative for surgeons and physicians to offer a minimally invasive, localized treatment of malignant lesions in the lung.

With the recent development, Medtronic continues to take an extensive transformative approach to the care continuum for the treatment of lung disease to advance diagnostics, optimize therapy and speed up recovery.

About Emprint Ablation Catheter Kit

In April 2021, the Emprint Ablation Catheter Kit received Breakthrough Device Designation status from the FDA and is currently in development. However, the device is not approved or cleared by the FDA and is not available for sale in the United States.

The catheter is designed to be used in combination with the Emprint microwave generator and Medtronic’s electromagnetic navigation bronchoscopy system to offer a highly localized treatment of malignant lesions in the lung. It can be used together with standard of care therapy when indicated.

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Medtronic will continue to study the safety and efficacy of the Emprint ablation catheter kit under an impending FDA investigational device exemption (IDE) study, with the objective to submit for device approval or clearance at a future date.

More on the NAVABLATE Study

NAVABLATE is a potential, multi-center study that registered 30 patients to portray the safety and performance of the CE Marked Emprint Ablation Catheter Kit in the United Kingdom and Hong Kong.  All patients underwent a bronchoscopic ablation procedure using the Emprint Ablation Catheter Kit and were followed for a month post procedure.

Study Outcome

The NAVABLATE study highlights the much-expected safety and performance results on microwave ablation used bronchoscopically with the Emprint Ablation Catheter Kit with Thermosphere Technology in combination with the Medtronic electromagnetic navigation bronchoscopy system.

The study demonstrated that bronchoscopic microwave ablation is an alternative for primary and oligometastatic malignant lung nodules £30mm in patients who decline or are not candidates for both surgery and stereotactic body radiation therapy.

Ablation using the Emprint Ablation Catheter Kit achieved 100% technical success (nodule reached and ablated in accordance with the study protocol) in all 30 patients, immediately post-procedure.

Industry Prospects

Per a report by Grand View Research, the global tumor ablation market size is estimated to reach $2.4 billion by 2028, at a CAGR of 13.2%.  The increasing incidence of cancer and high demand for effective treatment options are the major factors driving the market.

Moreover, increasing inclination toward minimally invasive procedures due to benefits such as speedy recovery, patient comfort, and shorter turnaround time are the factors expected to drive demand for advanced tumor ablation techniques.

Recent Developments

In July 2021, Medtronic announced the first gynecological (GYN) procedure with the Hugo robotic-assisted surgery (RAS) system. Globally, more than 60% of hysterectomies are performed as open procedures, even though minimally invasive surgery provides lesser complications, shorter hospital stays, and faster return to normal activities.

In the same month, Medtronic announced the integration of the Hugo robotic-assisted surgery (RAS) system at Hospital Clinico de la Red de Salud UC CHRISTUS in Santiago, Chile, to help the teaching institution's new robotic surgery program. The Hugo RAS system combines the precision of wristed instruments with the flexibility of independent robotic arm carts and best-in-class 3D visualization technology on an open console.

Price Performance

Shares of the company have gained 26.2% in a year’s time compared with the industry’s rise of 13.6%.

Zacks Rank and Key Picks

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

A few better-ranked stocks from the broader medical space are Envista Holdings Corporation NVST, BellRing Brands, Inc. BRBR and Henry Schein, Inc. HSIC, each carrying a Zacks Rank #2 (Buy). You can see the complete list of Zacks #1 Rank (Strong Buy) stocks here.

Envista Holdings has an estimated long-term earnings growth rate of 27%.

BellRing Brands has an estimated long-term earnings growth rate of 29%.

Henry Schein has a projected long-term earnings growth rate of 14%.



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