Recently, the US Food and Drug Administration (FDA) issued an early alert regarding the Atherectomy Catheter System, a plaque removal device from Bard Peripheral Vascular, a subsidiary of Biddy Medical, which may pose serious safety risks.

It is reported that the device has caused 4 deaths and 30 injuries, and BD Medical has also reported 115 cases requiring additional intervention after the spiral was broken or damaged. This news has attracted widespread attention from the medical community and the public.

Peripheral involvement in celebrity products
Bard Peripheral Vascular was formerly known as C R. Bard。 In 2017, BD Medical acquired C. for a huge amount of $24 billion R. Bard， From then on, C R. Bard became a wholly-owned subsidiary of BD Medical and was renamed Bard Peripheral Vascular.

Bard Peripheral Vascular primarily provides a range of surgical and interventional medical devices for the treatment of peripheral vascular diseases, venous diseases, dialysis access, dialysis maintenance, as well as cancer detection and treatment for Biddy Medical. Its products are rich and diverse, such as Bard Carbo Flo PTFE Straight Grafts and other different specifications of grafts, aimed at reducing early graft failure caused by thrombosis. It has good clinical effects in infrapopliteal artery and distal bypass surgery, and is an economical and effective alternative to drug therapy.

The Atherectomy Catheter System, which was warned by the FDA this time, is a plaque removal device and is also known as a vascular "cleaner". It is a star product in the peripheral intervention pipeline of BD Medical. This product can accurately target high-risk plaques and thrombi in peripheral arteries through high-speed rotation. Used for crushing and removing thrombus in natural peripheral arteries or peripheral arteries with stents, stent grafts, or natural or artificial bypass. Under normal circumstances, it can efficiently complete tasks, which benefits many patients as well.

The reason why the FDA issued a warning for this product is that the spiral part of the product rotates at high speed, which may pose a risk of fracture or damage when subjected to certain stresses, wear, high temperatures, friction, or local pressure. The use of this device under specific anatomical structures and lesion types, as well as certain operational factors, may result in spiral rupture or breakage, requiring the removal of broken catheter and/or device fragments. Spiral rupture or breakage may cause vascular damage and may lead to severe bleeding or death.

On February 5th, Bard Peripheral Vascular quickly responded to the incident and sent a Medical Device Correction letter to the customer regarding operations related to the spiral part of the plaque removal system. And updated usage instructions were released, providing additional training for clinical doctors on the Bidi website.

In the correction letter, Biddy stated that certain patient anatomical features have been identified, including the size, angle, tortuosity, degree of calcification, and procedural factors of blood vessels, such as contralateral entry, intrathecal involvement, lack of continuous blood flow, and factors related to catheter advancement, which may lead to spiral fissures and spiral fissures and fissures and spiral splits.

At the same time, Bard Peripheral Vascular also specifically warns users not to use these devices to treat calcified vascular segments, nor to use the device on container bifurcations or curves, which can cause curvature of catheter shafts with diameters <4 cm.

It is worth noting that the FDA has not yet classified this issue as a recall, but has issued an early warning and stated that it is reviewing relevant information, promising to promptly release any new information. The FDA will decide whether to recall based on the review results, which not only affects Bard Peripheral Vascular and BD Medical, but also relates to the treatment arrangements of medical institutions and patients.

Breaking up: First quarter financial report exceeds expectations
In recent years, BD Medical has frequently released heavyweight information. In addition to the incident of this safety incident, its series of decisions to "abandon and leave" have also sparked heated discussions in the industry.

In April 2022, BD Medical announced that it would complete the separation of diabetes care business and turn it into a listed company called Embecta. Embecta has become an independent company focusing on diabetes care. Its business includes developing, manufacturing and selling insulin delivery equipment (such as pen needles, syringes, etc.). After the spin off was completed, Embecta issued $200 million in senior unsecured notes to Bidi and paid approximately $1.266 billion in cash. Bidi no longer holds any shares in Embecta after the spin off.

In June 2023, BD Medical sold its surgical instrument platform to Steris for $540 million. Selling includes V Mueller ™、 Snowden-Pencer ™ And Genesis ™ Three major brands of surgical instruments, laparoscopic instruments, and sterilization containers. Steris also acquired three manufacturing plants from Biddy located in St. Louis, Missouri, Cleveland, Ohio, and Tuttlingen, Germany.

At the beginning of 2025, BD Medical once again released a heavyweight message and appeared with a completely new look (recommended reading: just now! BD Medical officially announced the "split" of its life science business). On February 6th, BYD Medical officially announced that it will spin off its life sciences business to strengthen its strategic focus and growth oriented investment and capital allocation, and create value for shareholders. The spin off plan is expected to be completed in the 2026 fiscal year. The spun off life science business will independently operate the life science tools and diagnostics business, focusing on high growth areas such as flow cytometry, microbiological testing, and molecular diagnostics.

On the day of the announcement of the spin off information, BD Medical also brought its Q1 2025 financial report, which showed that BD Medical exceeded expectations in terms of revenue, profit margin, and earnings per share.

The first quarter revenue reached 5.2 billion US dollars (approximately 37.9 billion RMB), a year-on-year increase of 9.8%.

GAAP earnings per share were $1.04, a year-on-year increase of 8.3%; Adjusted earnings per share were $3.43, a year-on-year increase of 28.0%.

In terms of business, the revenue of the medical department was 2.615 billion US dollars, a year-on-year increase of 17.3%; The revenue of the life sciences department was 1.297 billion US dollars, a year-on-year increase of 0.7%; The revenue of the intervention department was 1.257 billion US dollars, a year-on-year increase of 5.8%.

The first battle of the new fiscal year has started smoothly. Based on good performance, BD Medical has raised its full year forecast adjustment: the company has raised its adjusted earnings per share forecast for the 2025 fiscal year to $14.30 to $14.60, reflecting the company's strong performance in the first quarter and confidence in full year growth.

Conclusion
The safety risk event of Atherectomy Catheter System once again sounds the alarm for product safety, operating standards, and other aspects of the medical device industry. But currently, there is still uncertainty regarding the follow-up of this product, BD Medical. The FDA is reviewing information about potential high-risk device issues. If further review reveals that the problem is indeed very serious and involves the safety of a large number of patients, then a recall may be an unavoidable choice.

Source: https://news.yaozh.com/archive/44976.html