Amber Implants VCFix® spinal system obtains US FDA Breakthrough designation 

On October 05, 2021, the US Food and Drug Administration (FDA) granted the Breakthrough Device Designation to VCFix® spinal system, a next-generation spinal implant for spinal injuries developed by Amber Implants, a Netherlands-based company. 

Dr. Banafsheh Sajadi, Founder and CEO of Amber Implants, said that receiving the US FDA Breakthrough Designation is a significant recognition that will boost their efforts to bring VCFix® to patients. This development expedites their timeline significantly, with their First-In-Human clinical trial anticipated to start in early 2022 in Europe and the US, taking us one step closer to enhancing the quality of life of patients with vertebral fractures. 

According to DelveInsight’s Spinal Cord Injury Market,’ the total Spinal Cord Injury prevalent population in 7MM was 652,542 in 2017. These cases will increase with a substantial CAGR during the study period (2017–2030). 

According to analysts, the patient burden is high in case of vertebral fractures. At present, these injuries are treated with an injection of PMMA bone cement into the vertebra, and 65% of the patients are facing various types of side effects after treatment. Thus, the approval of the VCFix® spinal system will bring the necessary change in the market as it is the first solution to treat vertebral fractures that do not rely on bone cement and heal naturally. The Amber Implants is expected to gain a significant market share after its launch in the market.

iotaMotion secures De Novo request to market the iotaSOFT™ Insertion System

On October 05, 2021, iotaMotion Inc., a leader in developing advanced surgical systems for cochlear implant surgery, received approval from FDA for its’ De Novo classification request to market the iotaSOFT™ insertion system. The system is the world’s first and only robotic-assisted insertion technology expected to aid surgeons in placing cochlear implant electrode arrays by monitoring the speed of implant insertion. 

It is anticipated to become a fixture in the cochlear implant space, designed as a small, thumb-sized, open platform robotic technology, which is compatible with several implants and fits seamlessly into existing surgical workflows.

Christopher Kaufmann, MD, President, and CEO of iotaMotion, said they are excited to introduce the iotaSOFT insertion system, which objectively proffers precision and control beyond human capability. They are eager to begin the commercialization of this first-of-its-kind technology. The iotaSOFT system advances its vision of creating a suite of integrated capabilities to proffer robotic precision, operative data analytics, and real-time guidance to all surgeons as they work together to enhance patient outcomes.

According to DelveInsight’s ‘Age-related Hearing Loss Market & Competitive Landscape, the analyst estimates that the iotaSOFT system is expected to boost the requirement for cochlear implantation, as the surgeons will be able to place the electrode into the delicate, tiny structures of the cochlea with the further precision and stability that robotic assistance proffers. The company has planned a controlled commercialization schedule, which will benefit healthcare professionals and patients in the coming months.

Boston Scientific declares positive late-breaking clinical trial data for the Ranger™ Drug-Coated Balloon

On October 05, 2021, Boston Scientific declared positive results 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 study data comprise two-year results from the RANGER II SFA randomized controlled trial, approving the safety and efficacy of the Ranger DCB when compared to standard percutaneous transluminal angioplasty (PTA) for the treatment of Peripheral Artery Disease patients in the superficial femoral artery (SFA) and proximal popliteal artery (PPA).

The two-year results discovered that the Ranger DCB showed a tremendous higher primary patency rate of 84.0% than 71.4% percent in patients treated with standard PTA. It was also found to benefit with more excellent long-term patency in patients with more complex lesions treated with the Ranger DCB, exhibiting an 89.1% versus 72.4% primary patency rate in the moderate to severe calcium subgroup (p=0.0052) and a 76.6% compared to a 58.6% primary patency rate in patients with chronic total occlusions (p=0.1038)

Ravish Sachar, M.D., UNC Rex Hospital physician-in-chief for Heart and Vascular services and principal investigator of the RANGER II SFA trial, said that these two-year data show a sustained, high rate of efficacy including in patients with more complex lesion subtypes, yet another proof point for physicians to consider when determining the best-individualized treatment option for their Peripheral Artery Disease patients.

According to DelveInsight’s analyst, these positive results for the Ranger™ Drug-Coated Balloon (DCB) are expected to boost the confidence among physicians to opt for the treatment. Thus, helping Boston Scientific to gain market share and expand its reach.

Boston Scientific announces acquisition of Baylis Medical Company Inc.

On October 06, 2021, Boston Scientific Corporation entered into a definitive agreement to acquire Baylis Medical Company Inc. for an upfront payment of USD 1.75 billion. This transaction is anticipated to be completed by the first quarter of 2022. This will help Boston Scientific expand its electrophysiology and structural heart product portfolios by introducing the radiofrequency (RF) NRG®, and VersaCross® Transseptal Platforms and a family of guidewires sheaths and dilators utilized to support left heart access.

Baylis Medical Company is anticipated to generate net sales of around USD 200 million in 2022, having achieved double-digit year-over-year sales growth during each of the past five years.

Mike Mahoney, chairman, and chief executive officer, Boston Scientific, said that the talented and innovative Baylis Medical Company team, combined with these transseptal platforms, will improve their efforts for procedural efficiencies with physician tools designed to make left atrial access safer and more predictable, with an aim for patient outcomes. A leader in many of the fastest-growing markets in their industry, they suppose that Baylis Medical Company will add worthwhile revenue, operating income, and new research and development capabilities across multiple Boston Scientific businesses while complementing existing offerings within their electrophysiology and structural heart portfolios.

According to DelveInsight’s analyst, the acquisition is expected to benefit both Boston Scientific Corporation and Baylis Medical Company Inc., as Boston Scientific will expand its portfolio and secure market leadership with access to Baylis Medical products to a large population.

ReCor Medical introduces the Paradise™ Ultrasound Renal Denervation for Hypertension treatment in Europe

On October 06, 2021, ReCor Medical, Inc., a wholly-owned subsidiary of Otsuka Medical Devices Co., Ltd., launched the Paradise™ Ultrasound Renal Denervation System to treat uncontrolled hypertension in Germany. The first hospitals performing the procedure commercially are Heart Center Leipzig and Saarland University Hospital, Homburg/Saar.

Prof. Felix Mahfoud of Saarland University Hospital and chairman of the Arterial Hypertension Working Group of the German Society of Cardiology (DGK), said that many patients flunk despite the availability of antihypertensive medications to control their hypertension. Clinical data from the ACHIEVE, RADIOSOUND, RADIANCE-HTN SOLO, and TRIO trials show that ultrasound renal denervation with the Paradise System can decrease blood pressure and is a new treatment option for physicians to help their selected patients. They are pleased to be one of the first hospitals in Europe to proffer renal denervation with ultrasound.

According to the analyst, hypertension has been a leading contributor to disease burden worldwide and has increased cost to healthcare systems. The launch of the Paradise System in Europe is expected to benefit patients and lead an improved life. The company is expected to gain an outstanding share, one of the first companies to introduce the treatment. ReCor is currently conducting its FDA IDE pivotal study, RADIANCE-II, and pending successful completion, will submit for PMA approval to market the therapy in the United States.

Natera announces completion of the largest prospective validation study of a commercial Cell-Free DNA Test in Lung Transplantation

On October 06, 2021, Natera, Inc., a leader in improving patient outcomes through genetic and cell-free DNA (cfDNA) testing, declared the completion of the VALID Study (Validation for Allograft Lungs Implementing Donor-derived cell-free DNA) for Prospera™ in lung transplant recipients.

The study was conducted by The Ohio State University (OSU) lung transplant program examined 204 plasma samples obtained with concurrent bronchoscopy biopsy procedures from 104 lung transplant recipients between September 2020 and June 2021. It captured around 35 episodes of acute rejection. This study represents the largest prospective trial of a commercial dd-cfDNA test for lung transplant assessment.

Brian Keller, M.D., Ph.D., associate professor of medicine in the division of pulmonary and critical care medicine at OSU and the study’s principal investigator, said that they are proud to partner with Natera, a leader in dd-cfDNA testing, on this critical study as they seek to enhance outcomes for lung transplants patients by exploring new technologies and advancing the standard of care. The acceptance of this late-breaking abstract underscores the transplant community’s interest in the Prospera test and the potential for dd-cfDNA testing after lung transplantation. David Ross, M.D., FCCP, medical director of lung transplantation at Natera, said that the Prospera test had been clinically validated as a tool for assessing both kidney and heart rejection in transplant patients, and they are thrilled to confirm it for lung transplant assessment as well. They look forward to the strong results being presented at the upcoming CHEST annual meeting. Their goal is to offer the most accurate tests to aid physicians diagnose early rejection and ultimately improve health outcomes for thousands of patients.