A blog about what is new (and old) in the world of active implantable medical devices

Monthly Archives: October 2013

Quallion Being Acquired by EnerSys. Medical Battery Technology Said to be Key Strategic Priority.

Posted on by Posted in AIMD Business, Power Sources, Quallion, Rechargeable Batteries

Quallion logo

EnerSys, a global leader in stored energy solutions for industrial applications, announced that it has entered into an agreement to acquire Quallion LLC, a manufacturer of lithium ion cells and batteries for high integrity applications for $30 million.   Quallion’s innovative cells – especially rechargeable Zero-Volt ™ lithium-ion batteries – are used in quite a few implantable devices.

According to the press release:

Headquartered in Sylmar, CA, Quallion’s products include lithium ion cells and batteries for diverse applications including medical devices, defense, aviation and space. The closing of the transaction is subject to customary closing conditions.

Continue reading→

Changes in EU Rules for Medical Device Approvals

Posted on by Posted in AIMD Business

IPG with CE Mark

There has been some discussion in Europe over the last year to tighten the rules for medical device approvals. This discussion arose due to some scandals with breast implants in recent years.  One of the things being considered was a regulatory approval process similar to the PMA process in the US. The European Parliament has just voted this down, which is great news for our industry.

They did agree on some stricter requirements for Notified Bodies, specifically the following:

  • Notified Bodies must maintain in-house staff members rather than subcontractors to assess medical devices for CE Marking
  • A new group of Notified Bodies should be formed to evaluate higher-risk devices (such as implants)
  • More access to medical device clinical data for patients and healthcare providers
  • New requirements for reprocessing single-use devices
  • Separate legislation addressing IVD safety

These new rules will need to be approved by the EU members states so this is by no means final, but they are expected to have an impact on future AIMD development and approval.

St. Jude Q3 2013 AIMD Results: CRM Down 1%, Neuromodulation 3% Up

Posted on by Posted in AIMD Business, St. Jude Medical

logo_StJudeMedical

From today’s press release:

Cardiac Rhythm Management (CRM)

Total CRM sales, which include implantable cardioverter defibrillator (ICD) and pacemaker products, were $682 million for the third quarter of 2013, a 1 percent decrease compared to the third quarter of 2012. After adjusting for the impact of foreign currency, total CRM sales were flat.

Of that total, ICD product sales were $418 million in the third quarter, a 1 percent increase compared to the third quarter of 2012. ICD revenue increased 2 percent after adjusting for the impact of foreign currency.

Second quarter pacemaker sales were $264 million, a 5 percent decrease compared to the third quarter of 2012. On a currency neutral basis, pacemaker revenue declined 3 percent.

Neuromodulation

St. Jude Medical sales of neuromodulation products were $104 million in the third quarter of 2013, up approximately 3 percent from the prior year on a reported and currency neutral basis.

 

Neuros Medical Receives IDE Approval to Conduct Pivotal Study

Posted on by Posted in Nerve Blocking, Neuros Medical, Pain

Neuros Medical Altius www.implantable-device.com David Prutchi PhDNeuros Medical received an Investigational Device Exemption to conduct a pivotal clinical trial to evaluate the Altius™ System High Frequency Nerve Block technology for the management of intractable limb pain of amputees.   The prospective, randomized, controlled pivotal clinical trial will consist of 130 patients at 15 institutions in the U.S. to evaluate the safety and efficacy of Neuros Medical’s Altius System.

 

St. Jude Acquires Nanostim, Announces CE Mark of World’s First Leadless Pacemaker

Posted on by Posted in AIMD Business, Bradycardia, Cardiac Pacing, Nanostim, St. Jude Medical

cbhayden@me.com

St. Jude Medical today announced the completion of its acquisition of Nanostim, Inc., a privately-owned developer of miniaturized, leadless pacemakers. The acquisition adds the world’s first and only leadless pacemaker to the St. Jude Medical product portfolio.

httpv://youtu.be/P6PLiyzatOo

According to the press release:

Unlike conventional pacemakers that require a more invasive surgery, the Nanostim™ leadless pacemaker is designed to be implanted directly into the heart via a minimally invasive procedure. The device is delivered using a steerable catheter through the femoral vein, eliminating the need to surgically create a pocket for the pacemaker and insulated wires (called leads) that have historically been recognized as the most vulnerable component of pacing systems. The Nanostim leadless pacemaker recently received CE Mark approval and will be available soon in select European markets. It also recently received U.S. Food and Drug Administration (FDA) conditional approval for its Investigational Device Exemption (IDE) application and pivotal clinical trial protocol to begin evaluating Nanostim leadless technology in the U.S.

Continue reading→

FDA Panel Majority Votes Against Effectiveness of CardioMEMS CHAMPION HF Monitoring Device

Posted on by Posted in CardioMEMS, Heart Failure (CHF), St. Jude Medical, Telemetry

CardioMEMS miniature implantable sensor for heart failure and aneurism management

Although the FDA advisory panel found CardioMEMS’ CHAMPION HF Pressure Measurement System to be safe, on October 9, 2013, the majority of panel members decided that the implantable sensor monitor to help guide treatment in patients with congestive heart failure is not effective.

According to Forbes, one panel member said it was difficult to connect the dots between use of the monitor and decreased hospitalization and lack of data on use in women.

This is not the first time that CardioMEMS attempts to receive PMA approval.  In 2011 FDA rejected the Champion implantable monitoring system for heart failure for premarket approval, in part due to questions about the validity of presented data. Last year, CardioMEMS received an FDA Warning Letter.