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Boston Scientific's (BSX) Ranger DCB Trial Outcome Favorable

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Boston Scientific Corporation BSX recently announced favorable outcomes for the Ranger Drug-Coated Balloon (DCB) during a late-breaking clinical trial presentation at the Vascular InterVentional Advances (VIVA) meeting in Las Vegas.

The clinical data included two-year results from the RANGER II SFA randomized controlled trial, representing the safety and efficacy of the Ranger DCB compared to traditional percutaneous transluminal angioplasty (PTA) for the treatment of patients with peripheral artery disease (PAD) in the superficial femoral artery (SFA) and proximal popliteal artery (PPA).

The recent development is likely to strengthen Boston Scientific’s Cardiovascular portfolio.

Study Outcomes

Following the positive one-year results of RANGER II SFA, which were published in the Journal of American College of Cardiology, the new two-year results validated that the Ranger DCB showed a significantly higher primary patency rate of 84% compared to 71.4% in patients treated with the standard PTA.

Subgroup analyses found consistent benefits with greater long-term patency in patients with more complex lesions treated with the Ranger DCB, demonstrating 89.1% primary patency rate compared with 72.4% registered in the moderate-to-severe calcium subgroup.

The Ranger DCB, which has a low drug dose density of paclitaxel, also demonstrated a significant reduction in reinterventions at two years with a freedom from target lesion revascularization (TLR) rate.

Significance of Ranger DCB

The two-year data for Ranger DCB demonstrates a constant, high rate of efficacy in patients with more complex lesion subtypes, thus representing another proof point for physicians to consider while determining the best customized treatment option for their patients with PAD.

Ranger DCB demonstrated outstanding, sustained results at two years and it is mostly gratifying that the RANGER II SFA subgroup analyses found no reintervention disadvantage for women, who have traditionally experienced higher patency challenges following endovascular intervention for PAD.

Industry Prospects

Per an EMERGEN Research report, the global interventional cardiology devices’ market size was $15.14 billion in 2013 and is expected to reach $26.84 billion by 2028, seeing a CAGR of 8.7%.

Growing adoption rates of minimally invasive surgeries, the increasing global prevalence of cardiovascular diseases and technological advancements are the factors driving the market.

Boston Scientific’s Developments in Cardiovascular Space

In September 2021, Boston Scientific announced an agreement to acquire Devoro Medical, Inc., which develops the WOLF Thrombectomy Platform. Per management, once commercialized, the WOLF technology will complement and enhance the company’s offerings to a full suite of interventional strategies for thromboemboli, which also incorporates the EkoSonic Endovascular System and the AngioJet Thrombectomy System.

In July 2021, Boston Scientific announced favorable 24-month results from the PINNACLE FLX clinical trial, assessing the safety and efficacy of the next-generation WATCHMAN FLX Left Atrial Appendage Closure (LAAC) device for patients with non-valvular atrial fibrillation (NVAF). The study evaluated the WATCHMAN FLX device as a substitute for the long-term oral anticoagulation therapy including non-vitamin K antagonist oral anticoagulants (NOACs) for stroke risk reduction in patients with NVAF.

Developments by Other Companies

At present, Boston Scientific is facing a tough competition in the field of cardiovascular space from companies like Abbott Laboratories ABT, Medtronic plc MDT and Edwards Lifesciences Corporation EW.

In September 2021, Abbott announced the receipt of the FDA approval for its Amplatzer Talisman PFO Occlusion System to treat people with a patent foramen ovale (PFO), a small opening between the upper chambers of the heart who are at the risk of recurrent ischemic stroke. Per Abbott’s management, with the new Talisman system, doctors can treat a wider range of patient anatomies and the preparation needed for PFO occlusion procedures is simpler and faster in the United States.

During the same month, Medtronic collaborated with Mpirik to launch the pilot program focused on addressing disparities in care with respect to the prevention of sudden cardiac arrest (SCA). Vizient, a healthcare performance improvement organization that offers data and analytic insights,also joined Medtronic and Mpirik under this pilot program.

In July 2021, Edwards Lifesciences presented clinical and economic results from the 3M (multidisciplinary, multimodality but minimalist) Transcatheter Aortic Valve Replacement (TAVR) Economic Study and the PARTNER 3 Bicuspid Registry for SAPIEN 3 TAVR Study. The 3M-TAVR study demonstrated positive findings supporting similar outcomes and significant cost savings associated with minimalist TAVR compared with conventional TAVR in patients at an intermediate risk for surgery.

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