Archives: 3/2010

774634hh Abbotts Bioresorbable Stent Continues to Prove Itself in TrialsAt the American College of Cardiology’s 59th annual scientific session in Atlanta this week, Abbott released results of a Phase 2 clinical trial of its bioresorbable vascular scaffold (BVS). In this 30 day trial, the new stenting technology has led to no thrombosis, no ischemia-driven target lesion revascularization, and a rate of major adverse cardiac events was only 2 percent.
From the announcement:

This second phase of the ABSORB clinical trial (Cohort B) enrolled 101 patients from 12 centers in Europe, Australia and New Zealand, and incorporates device enhancements designed to improve deliverability and vessel support.Abbott is the only company with long-term, three-year clinical data on a complete patient set evaluating the safety and performance of a fully bioresorbable drug eluting scaffold.
Abbott’s investigational BVS is made of polylactide, a proven biocompatible material that is commonly used in medical implants such as dissolving sutures. The bioresorbable technology is designed to restore blood flow by opening a clogged vessel and providing support until it is healed. Once the vessel can remain open without the extra support, the bioresorbable scaffold is designed to be slowly metabolized by the body, and is completely dissolved over time. Since a permanent implant is not left behind, a vessel treated with BVS has the ability to ultimately move, flex and pulsate similar to an untreated vessel. The potential to restore these naturally occurring vessel functions, or vascular restoration therapy, is what makes Abbott’s BVS unique in the field of cardiology.

Press release: Abbott Announces Positive Data From ABSORB Trial on Its Bioresorbable Vascular Scaffold Technology…
Flashbacks: Abbott’s Bioabsorbable Stent Showing Promise at Three Years ; Abbott’s Bioabsorbable Stent Earns High Marks in Clinical Trial; Abbott Reports Positive Data from Study of Its Bioabsorbable Drug Eluting Stent; Bioabsorbable Stents: So Far So Good

Eric Dishman, Intel’s Fellow of Digital Health Group and Director of Health Innovation and Policy, spoke at TEDMED last October on what the future holds for at-home healthcare. Dishman presents a few projects that Intel is working on in anticipation of the demographic changes that are expected to influence medical care around the world.


Link: TEDMED…

At last year’s TEDMED, magician Eric Mead gave a most unexpected talk about placebos. By using a bit of trickery, Mead demonstrated how knowledge of an event’s real nature is not enough to suppress belief in its perceived, but fake, action.


Link: TEDMED…

yy65edh Innova EPVision Unifies Tomography Data for Comprehensive Visualization
GE Healthcare is releasing a new radiological software package that brings together data from various modalities, like CT, MRI, and X-ray, into one volumetric visualization. The system also improves data coming off tomographs by managing blurring caused by organ movement during the original scans.

Built upon Innova’s exceptional 3D imaging platform, Innova EPVision provides image overlay and delivers gated image stabilization, reducing image artifact that can occur with patient movement, cardiac motion or breathing. During procedures, the gated image stabilization enables accurate visualization for better localization and guidance of ablation catheters and other devices during interventional procedures such a complex EP procedures.
GE’s Innova EPVision provides uncompromised registration performance of the 3D overlay on the 2D fluoroscopy with ECG gating and motion compensation. The application is enhanced by image stabilization features such as ECG gated display and motion tracking. These tools help reduce image motion that occurs with patient movement or breathing. Innova EPVision is available on GE’s Innova 2100IQ cardiovascular X-ray system along with the complete family of single-plane Innova systems from GE Healthcare.

Press release: GE Healthcare Provides Electrophysiologist Innova® EPVision To Navigate With Confidence During Complex Procedures …

339231jj Implanting Silicon Chips Into Cells May Soon Become a Possibility
Michael Berger at Nanowerk is reporting on recent research out of Spain to embed microelectronics within living cells, a feat that promises to provide intracellular sensing for research and medical monitoring applications. Turns out we’re not very far away from this reality due to the nanoscale production of modern microprocessors.
A tidbit from Nanowerk:

In their experiments, the Spanish team fabricated different batches of polysilicon chips and then chose the most suitable device type with lateral dimensions of 1.5-3μm and with a thickness of 0.5 μm to be placed inside living cells. Cells were taken from Dictyostelium discoideum and human HeLa cells.
To further demonstrate the versatility of the technique, they studied the integration of different materials in a single chip and their 3D nanostructuring capability by using other common microelectronics techniques such as FIB milling.
After inserting the chips into the live cells, the researchers made sure that the cells remained alive and healthy. They found that over 90% of the chip-containing containing HeLa cell population remained viable 7 days after lipofection.

Read on at Nanowerk: Future bio-nanotechnology will use computer chips inside living cells…
Abstract in Small: Intracellular Silicon Chips in Living Cells

772340 New Radioisotope Supplier to Fill Gaping Hole in MarketDue to the continued closure of Canada’s Chalk River reactor, a major supplier of medical radioisotopes, and the historic limited capacity within the nuclear medicine supply industry, there has been a serious shortage of radiomarkers on the market.

To address this problem, Covidien just received the FDA go ahead to source molybdenum-99 radioisotope from Poland’s Maria nuclear research reactor (pictured) to produce technetium-99m for medical applications.

The fairly short lived isotope is used in approximately 80% of nuclear diagnostic procedures, and the initial supply, which should be available next month in the US and Canada, should provide enough material for one million procedures in the first six months.

Press release: U.S. FDA and Health Canada Approve Use of Molybdenum 99 From Maria Reactor …

Image: Maria reactor. Credit: Wikimedia Commons

medtronic soletra Medtronics DBS Therapy for Epilepsy May Yet Get FDA ApprovalAn FDA advisory panel has voted 7 to 5 in favor of approval of Medtronic’s deep brain stimulation (DBS) device, probably the Soletra, as a treatment option for medically refractory epilepsy in certain patients. The device, already approved for Parkinson’s, was only days earlier reported to have failed an important study goal. Now it is seeing new life, and potential approval, due to a kink in the latest study.
Jennifer Corbett Dooren at the Wall Street Journal explains:

A study of the device was conducted in 110 patients, but it failed to meet a study goal that looked at a reduction in the seizure rate over a three-month period.
However, the FDA said that when looking at just the third month of treatment, patients being treated with the deep-brain-stimulation device had a greater reduction in seizures compared with patients whose device was not activated.
The missed study goal was influenced by one patient who developed a different type of seizure after the device was turned on, both the FDA and Medtronic said. When the device’s power was lowered, the seizures stopped.
Medtronic asked the FDA and the panel to consider the data without the one patient, which would result in the study meeting the three-month goal, or to consider the last month of the three-month period. But the panel was divided on whether the patient should be removed from the analysis of the study.

Wall Street Journal from March 10: Medtronic Brain Stimulator Missed Study Goal
Wall Street Journal from March 12: FDA Panel Backs Device For Epilepsy
Medtronic press release: FDA Panel Recommends Approval with Conditions of Medtronic Deep Brain Stimulation Therapy for Patients with Refractory Epilepsy …
Flashback: Medtronic’s Deep Brain Stimulation Devices Approved for Parkinson’s and Essential Tremor

sserweeejj Rex Medical Cleaner  Rotational Thrombectomy System Wins US Green LightRex Medical of Conshohocken, Pennsylvania won regulatory approval from the FDA to sell its Cleaner Rotational Thrombectomy System. The atherectomy system is based around a battery powered Cleaner device that rotates a tip at 4,000 RPM for drilling through arterial plaque.

  • 6Fr ergonomically designed, hand-held, battery operated drive unit
  • 6Fr introducer sheath compatibility
  • Atraumatic, effective wall contact and thrombus maceration with particulate aspiration through an introducer sheath
  • Superior trackability and steerability through tortuosity
  • Decreased procedural time and cost
  • Single use, disposable
  • Cleaner Device Specifications:
    Wire:

  • 0.035 inch diameter
  • Radiopaque tip
  • Catheter:

  • 6Fr shaft outer diameter
  • 65cm & 135cm length
  • Drive Unit:

  • Battery operated
  • 4,000 rpm
  • Press release: Rex Medical Cleaner™ Rotational Thrombectomy System Receives 510(k) Clearance …
    Product page: Cleaner …
    Flashbacks: Diamond Tipped 200,000 RPM Artery Drill ; Pathway Medical’s Peripheral Plaque Drill Gets 510(k) Classification

    mendor Mendor Portable Blood Glucose Meter Announced
    Mendor, a new company out of Helsinki, Finland, is preparing to launch a new blood glucose meter that is promised to be easier and more discreet to use than currently available models. The device, soon to be available in Europe, has a built in mechanical lancer and test strips. This makes it a convenient, self contained package, about the size of a cell phone, that doesn’t require additional components to be brought along. Details about the device are still slim, but we’ll be providing those once they become available.
    More from Amy Tenderich at DiabetesMine: New Cellphone-Like All-in-One Glucose Meter from Finland…
    Link: Mendor Blog…