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BD's (BDX) Rotarex Atherectomy System Gets FDA 510 (k) Clearance

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Becton, Dickinson and Company (BDX - Free Report) , also popularly known as BD, recently received 510(k) clearance for expanded indications from the FDA for the Rotarex Atherectomy System. It is important to mention here that the Rotarex Atherectomy System is a rotational excisional device, which has been designed to remove and aspirate varying legion morphologies that include plaque and thrombus in peripheral arteries.

The device has already been cleared for usage in native arterial vessels and now equipped with the expanded indications can treat peripheral arteries fitted with stents, stent grafts, and native or artificial bypasses.

In fact, Rotarex Rotational Excisional Atherectomy System is the first and only atherectomy and thrombectomy device indicated to treat in-stent restenosis in the United States.

This clearance is likely to provide a boost to BD‘s BD Interventional business.

Significance of the Clearance

Interestingly, the FDA clearance of the Rotarex Atherectomy System’s new expanded indications come on the back of a decade of real-world clinical experience of treating thousands of patients worldwide.

Per management, the additional indications offer physicians an innovative, ideal solution for the treatment of complex lesions related to peripheral arterial disease (PAD).

PAD is a potentially crippling disease, which can result in higher risk of cardiovascular complications and limb amputation. If the arteries get blocked then treatment of PAD becomes necessary.

Industry Prospects

Per a report by Grand View Research, the global atherectomy devices market is projected to reach $957.8 million by 2026, witnessing a CAGR of 7% during the forecast period (2015-2026). Rapid increase in the incidence of target diseases like PAD and favorable patient outcomes with minimally invasive procedures are factors driving this market’s growth.

Hence, this clearance comes at an opportune time for BD.

Recent Developments

In August, BD announced the launch of BD COR System, a new and fully-automated high-throughput diagnostic system utilizing robotics and sample management software algorithms. The latest launch will make the BD Onclarity HPV (human papillomavirus) Assay with extended genotyping for the BD COR System available to high-throughput laboratories that currently process the majority of cervical cancer screening specimens across the United States.

Again, in the same month, the company announced the receipt of the FDA’s Emergency Use Authorization (“EUA”) for the BD Veritor At-Home COVID-19 Test. The test is an over-the-counter rapid antigen test that utilizes the Scanwell Health mobile app to deliver reliable results in 15 minutes.

Again, in August, the company announced the launch of a new benchtop cell analyzer, BD FACSymphony A1 Cell Analyzer. The fluorescence-activated cell analyzer is expected to equip laboratories of all sizes with sophisticated flow cytometry capabilities.

Other Notable Approvals

Some other companies in the medical space that have received regulatory approvals in recent times are PerkinElmer, Inc. (PKI - Free Report) , Abbott Laboratories (ABT - Free Report) and Thermo Fisher Scientific Inc. (TMO - Free Report) .

This month, PerkinElmer’s company, EUROIMMUN, announced that it has received the FDA’s EUA for its Anti-SARS-CoV-2 S1 Curve ELISA (IgG). This assay enables the qualitative and semi-quantitative detection of IgG antibodies produced against the SARS-CoV-2 S1 antigen in human serum and plasma.

In September, Abbott received the FDA approval for its Amplatzer Talisman PFO Occlusion System to treat patent foramen ovale (PFO) patients at risk of recurrent ischemic stroke. The next-generation Talisman system builds on the company’s industry-leading Amplatzer PFO Occluder.

Again, in September, Thermo Fisher gained pre-market approval from the FDA for its Oncomine Dx Target Test as a companion diagnostic (CDx) to detect patients with epidermal growth factor receptor (EGFR) Exon20 insertion mutation-positive metastatic non-small cell lung cancer (mNSCLC), who are eligible of becoming candidates for EXKIVITY (mobocertinib).