FDA Issues Early Warning on BD's Rotarex Device, Medtronic Acquires Nanovis Tech, and Henan Public Hospital Alliance Finalizes Interventional Device Procurement

Feb 16, 2025 19:06 CST Updated 19:06

Medtronic

Medical Device Manufacturer

Nanovis

Cervical and Lumbar Interbody Fusion Device Developer

Recently, the United StatesFDA Issues Early Warning on Potential High Risk of BD Peripheral Plaque Removal Device Rotarex

Rotarex is an important component and star product of BD's peripheral intervention portfolio. The spiral part of the device rotates at high speed, and when subjected to wear, high temperature, friction, or localized pressure, there is a risk of breakage or damage, which may lead to vascular injury and potentially cause severe bleeding or death. Reports indicate that this series of devices has caused 30 serious injuries and 4 deaths, with an additional 115 cases requiring extra interventions due to catheter rotor breakage.

The FDA has not yet issued a formal recall classification, and BD is continuing to investigate the potential factors that may have contributed to this issue.

The company recommends instructing users to use a sheath of the same size as the Rotarex atherectomy catheter, appropriately reinforced, but 1 French size larger. Users should also maintain sufficient blood flow within the catheter to reduce the risk of overheating or blockage. Additionally, users should keep the catheter in continuous motion to minimize fatigue stress on the helix at the same location.

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Medtronic Announces Latest Acquisition

Officially confirmed, Medtronic has acquired Nanovis' nano-surface technology assets and part of the intellectual property related to Sites Medical’s OsteoSync titanium pads, for the development of next-generation PEEK interbody fusion devices, further solidifying its leading position in the orthopedic field. Although the specific financial terms of the deal have not been disclosed, this acquisition undoubtedly highlights Medtronic's ambitious technology layout in niche areas.

Nanovis is a technology-driven company established in 2008, focusing on healing, designing, and manufacturing nanosurface technologies to improve biological fixation for orthopedic, spinal, and dental implants. The company is the world’s first to receive FDA approval and next-generation Ti+PEEK surface technology certification for interbody fusion devices (NanoFortiCore) and is also the world’s first and only company to receive FDA approval and nanotechnology certification for minimally invasive open pedicle screws (Nano FortiFix). It has been named the Best Nanotechnology-Driven Implant Company by Global Health and Pharma and listed as one of the top ten orthopedic solution providers by Med Tech Outlook.

Nanovis states that its bone growth nanotechnology can enhance the speed and consistency of human bone growth response. It improves implant fixation through enhanced osseointegration. In this process, bone grows and fuses with the surface of spinal implants.

Nanovis CEO Brian More stated, "We are thrilled to collaborate with Medtronic. By integrating our leading nanosurface technology with Medtronic's exceptional PEEK implant design, we look forward to providing more surgeons with top-tier treatment tools, ultimately benefiting a wide range of patients."

Medtronic's Endovascular Stent Graft System Approved for Marketing in China

Recently, the National Medical Products Administration approved the innovative product registration application for the "Aortic Stent Graft System" by Lifetech Scientific (Shenzhen) Co., Ltd.
This product is suitable for Stanford Type B dissection patients who require reconstruction of blood flow in the left subclavian artery, with a proximal anchoring zone length of ≥15mm. This product is the first chimney technique-dedicated stent graft system, featuring a dual-layer stent design with an outer skirt on the aortic branch stent. The outer skirt is designed to fill the gap between the stent and the vessel wall after deployment, which is expected to prevent and reduce endoleaks, thereby lowering the risk of complications.

Transcatheter Mitral Valve Clip System Approved for Marketing

Recently, the National Medical Products Administration approved the innovative product registration application for the "Transcatheter Mitral Valve Clip System" by Hangzhou Duan You Medical Technology Co., Ltd.
This product is suitable for patients with degenerative mitral regurgitation (MR≥3+) who are assessed by the cardiac team as having a high surgical risk and whose mitral valve anatomy is appropriate. The product adopts a wrapped lifting shape design, which is expected to achieve stable anchoring after implantation; it uses a four-channel control pathway design for anchoring components, enabling simultaneous or separate capture of the valve leaflets, which is expected to improve the success rate of surgery and reduce surgical risks.

First Case of Ankle Fusion Nail System Surgery Completed

Recently, the first surgery using Shotel Medical's Ankle Arthrodesis Nail for the treatment of advanced ankle arthritis was successfully completed.

Patients implanted with the Shotel Nail System are able to bear weight using a Controlled Ankle Motion (CAM) walking boot within two weeks post-operation, which is a significant advancement compared to the typical six to eight weeks of non-weight-bearing required by traditional ankle fusion surgeries. The curved design of the Shotel Nail allows for a minimally invasive approach, enabling the surgery to be performed through only small incisions. This system aims to fuse the tibiotalar joint while preserving full mobility of the surrounding joints, resulting in faster healing, quicker rehabilitation, and earlier weight-bearing capability for patients.

Shotel Medical, Inc. is a medical device company dedicated to developing and manufacturing high-quality medical devices for the treatment of end-stage ankle arthritis. The company was founded in 2017 and has offices in New Orleans, USA. Its flagship product is the Shotel™ Ankle Fusion Nail System, the first ankle fusion nail system to receive FDA approval. It is designed to achieve tibiotalar joint fusion while allowing all other joints to maintain unrestricted movement.

Two New Models of Electronic Gastrointestinal Endoscopes Receive Class II Registration Approval for Marketing

Recently, a new model of electronic upper gastrointestinal endoscope and electronic lower gastrointestinal endoscope from KaiLi Medical, as well as a new model of medical endoscopic image processor, have been approved for Class II registration by the Guangdong Provincial Medical Products Administration. Their registration numbers are Yue Medical Device Registration No. 20252060113, Yue Medical Device Registration No. 20252060115, and Yue Medical Device Registration No. 20252060114, respectively.

Currently, the product line of KaiLi Medical covers areas such as ultrasound medical imaging, endoscopic diagnosis and treatment, minimally invasive surgery, and cardiovascular intervention, providing professional and specialized overall solutions to medical institutions in more than 170 countries and regions worldwide. The endoscope product line includes endoscopic image processing systems, ultrasonic endoscope systems, gastrointestinal endoscopes, bronchoscopes, peripheral devices, and consumables.

Henan Public Hospital Alliance Centralized Procurement Finalized

Recently, the First Affiliated Hospital of Zhengzhou University released the "Announcement (VI) on the Continuation of Procurement for Neurointerventional Medical Devices by the Public Medical Institution Alliance," revealing the official selection results for neurointerventional devices.

This centralized procurement is the continuation of the Henan Province Public Medical Institutions Medical Consumables Procurement Alliance, covering two major categories: neurointerventional and peripheral interventional. On January 21 this year, the official website of the First Affiliated Hospital of Zhengzhou University disclosed the selection results of the two categories of consumables. However, after expert evaluation, a re-negotiation for all procurement directories of neurointerventional products was conducted, and the latest results have now been announced. According to the procurement documents, this alliance procurement involves 22 types of neurointerventional consumables and 45 types of peripheral interventional consumables. The selection results show that foreign giants such as ConvaTec, MicroVention, Stryker, and Medtronic still perform strongly, ranking first in multiple groups; however, domestic forces are also rapidly rising. Chinese brands including Xinmai Medical, LifeTech Scientific, Ceno Technologies, Guichuang Tongqiao, and Tianhong Shengjie have won bids on multiple fronts, and some products have broken the monopoly of foreign companies, ranking high in the corresponding groups, which will secure a significant market share.

In the first round of procurement by the Henan Public Hospital Alliance, the average price reduction for two types of consumables reached 53.6% across 2,323 product specifications. According to official disclosures, after the implementation of the procurement results, the estimated annual procurement expenditure for these two types of consumables in Henan Province will decrease from 2.46 billion yuan to 1.15 billion yuan, saving over 1.31 billion yuan.

Editor: Wanwan

Reviewed by: Zhang Song, Zhang Lanfei