Recently, Medtronic, the medical device giant, has had a series of exciting developments. Three cardiovascular products were successively approved, followed by the announcement of the appointment of Dr. Matthew Kroh as Chief Medical Officer (CMO) for Advanced and General Surgical Technologies.
Three products have been approved in succession.
Affera Radiofrequency Ablation System, Sphere-9 Catheter, Evolut FX+ Transcatheter Aortic Valve (from left to right)Affera Mapping and Ablation System
Affera Radiofrequency Ablation System, Sphere-9 Catheter, Evolut FX+ Transcatheter Aortic Valve (from left to right)
Latest Progress:Medtronic Announces FDA Approval of Affera Mapping and Ablation System in the U.S. The system integrates three technologies: 3D mapping (HD), radiofrequency ablation (RF), and pulsed field ablation (PFA), specifically designed for treating persistent atrial fibrillation and tricuspid isthmus-dependent atrial flutter.
Features:The system includes the Sphere-9™ catheter and Affera™ Prism-1 mapping software, which received CE mark approval in March 2023.
Meaning:The approval of the Affera system marks an important step for Medtronic in the field of electrophysiology, making it the world's first company to provide two FDA-approved PFA systems for atrial fibrillation treatment. In addition, Medtronic plans to launch the Sphere-360 catheter to further enhance ablation outcomes.Evolut FX+ Transcatheter Aortic Valve Replacement (TAVR) System
Latest Progress:Evolut FX+ TAVR System Receives CE Mark Approval for Treatment of Symptomatic Severe Aortic Stenosis (AS). The system was previously approved by the FDA in March 2024.
Features:The orifice size of Evolut FX+ is four times larger than the previous Evolut TAVR system, which helps better accommodate coronary arteries with different anatomical structures.
Meaning:This approval solidifies Medtronic's leading position in the field of structural heart disease.Notably, prior to acquiring Affera for $1 billion in 2022, Medtronic did not have its own mapping system. The recent approval of the Affera system has strengthened Medtronic’s position to compete with the other three major players in the electrophysiology field (Boston Scientific, Johnson & Johnson, and Abbott). Medtronic has also become the first company globally to offer two FDA-approved PFA systems for treating atrial fibrillation. Medtronic's PulseSelect PFA system received FDA approval in December 2023.
Medtronic will also launch the Sphere-360 for single-shot pulmonary vein ablation in the future. It can adjust the electrode shape according to the patient's physiological structure, thereby conforming to various pulmonary vein anatomical structures. Integrated perfectly with the Affera mapping and ablation system, it achieves minimal to zero fluoroscopy.
In addition to the cardiovascular product line, Medtronic's Surgical Division recently announced good news. According to foreign media reports, Medtronic officially announced the appointment of Dr. Matthew Kroh as Chief Medical Officer (CMO) for Advanced and General Surgical Technologies.
Dr. Matthew Kroh.
It is reported that Dr. Kroh is a Medtronic board-certified surgeon who previously served as the head of the Foregut and Surgical Endoscopy Department at the Cleveland Clinic, with extensive clinical experience.
Among them, he has deep professional knowledge in the treatment methods and new technology applications in the field of minimally invasive surgery, with expertise including advanced laparoscopic surgery, bariatric surgery, gastrointestinal surgery, surgical endoscopy, single-incision laparoscopic surgery, and robotic surgery.
After officially assuming his position, Dr. Kroh will continue to leverage his extensive clinical and medical leadership experience to guide Medtronic's surgical business in new product development and commercialization strategies. He also plans to continue performing surgeries at the Cleveland Clinic.
Regarding this appointment, Kroh stated, "I look forward to contributing to the development of surgical technologies that can expand access and improve outcomes for patients worldwide."
Medtronic, which is accelerating the layout of its surgical business, has high hopes for Dr. Kroh’s joining. The General Manager and Vice President of Advanced Surgical Technologies at Medtronic stated, "We are delighted to welcome Dr. Kroh to Medtronic. His experience in pioneering surgical innovations will be invaluable as we continue to advance the development of medical technology."
The reality is not smooth sailing.
Of course, as the saying goes, "It's lonely at the top," and the position of a medical device giant is certainly not easy to hold.
According to Medtronic's financial report for the first quarter of the 2023 fiscal year, revenue from all business segments declined, with total revenue amounting to $7.371 billion, a decrease of $718 million from the previous quarter. In addition to the underperformance of its core businesses, Medtronic’s surgical robotics project encountered manufacturing and supply chain issues, causing delays in product releases.
▲Figure: Shutterstock
In response to these challenges, Medtronic has taken a series of measures to streamline operations.At the 2024 JPMorgan Healthcare Conference held earlier this year, the company announced a significant restructuring plan aimed at improving efficiency and reducing costs through the following measures:
- Shut down at least five production facilities;
- Consolidate eight distribution centers into two super centers;
- Terminate cooperation with about 200 non-strategic suppliers to optimize operations and supply chain management.
At a high level, a sense of crisis constantly looms, especially under the intense competition within the industry. The fundamental purpose of this series of changes is nothing more than cost reduction and efficiency enhancement. Meanwhile, when a company enters a period of strategic transformation, one of the most intuitive manifestations is the management of human resources and the turbulence within the management team.
It's not just Medtronic; several international medical device giants are also undergoing personnel restructuring and strategic adjustments in their surgical businesses.
At the end of last year, Johnson & Johnson announced that it would sell its subsidiary Acclarent, which focuses on ENT (ear, nose, and throat) surgical business, to Integra LifeSciences, a leader in neuromodulation, for $280 million (approximately 2 billion RMB).
Vladimir Makatsaria, Chairman of the Group and head of Johnson & Johnson's surgical business, announced his departure from Johnson & Johnson Medical earlier this year.
In June last year, BD Medical announced that it had signed a definitive agreement to sell its surgical instruments platform to Irish medical device manufacturer STERIS for $540 million. BD stated that this divestiture is part of its 2025 strategy.
In addition, BD Medical is undergoing other business adjustments, including cutting approximately one-quarter of the workforce at its manufacturing plant in Drogheda, Ireland, as well as high-level personnel changes such as appointing a new president for the surgical business unit and a global president for the peripheral intervention business unit.
In the face of market volatility and internal adjustments, Medtronic has demonstrated the resilience and foresight expected of an industry leader. Through continuous technological innovation and talent acquisition, Medtronic has not only solidified its leadership position in the cardiovascular field but also opened new growth opportunities in surgical businesses. Despite short-term performance pressures and uncertainties in the external environment, Medtronic has shown unwavering confidence in its future development through proactive strategic adjustments and cost control. Going forward, we look forward to Medtronic making greater contributions to the healthcare industry, and Medical Device Innovation Network will continue to follow its progress.▲Source: Medical Device Innovation Network▲Unauthorized reproduction is prohibited, and reprinting is allowed only after 24 hours!Disclaimer: This article is intended solely for the purpose of information transmission and is for reference only. It does not constitute any advice on investment or treatment. Please exercise caution and discretion. If there are issues related to the content, copyright, or other aspects of the article, to ensure the rights and interests of both parties, please contact us and we will handle it immediately. If this article is reprinted by any platform, the platform shall be responsible for the content of the article itself. The Medical Device Innovation Network is not responsible for any secondary dissemination caused by reprinting.
